Angioplasty balloons
Saber .035
A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.
Find similar PTA balloons
Where to buy Saber .035
We do not have contact details for Cordis US Corp. yet. Send a request and we will route it to the right person for your country.
Saber .035 models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| 48003002N | Length 80 cm | Not stated | Available |
| 48003002P | Length 40 cm | Not stated | Available |
| 48003004N | Length 80 cm | Not stated | Available |
| 48003004P | Length 40 cm | Not stated | Available |
| 48003004R | Length 135 cm | Not stated | Available |
| 48003006N | Length 80 cm | Not stated | Available |
| 48003006P | Length 40 cm | Not stated | Available |
| 48003006R | Length 135 cm | Not stated | Available |
| 48003008N | Length 80 cm | Not stated | Available |
| 48003008R | Length 135 cm | Not stated | Available |
| 48003010N | Length 80 cm | Not stated | Available |
| 48003010P | Length 40 cm | Not stated | Available |
| 48003010R | Length 135 cm | Not stated | Available |
| 48003012N | Length 80 cm | Not stated | Available |
| 48003012R | Length 135 cm | Not stated | Available |
| 48003015N | Length 80 cm | Not stated | Available |
| 48003015R | Length 135 cm | Not stated | Available |
| 48003020R | Length 135 cm | Not stated | Available |
| 48003025N | Length 80 cm | Not stated | Available |
| 48003025R | Length 135 cm | Not stated | Available |
| 48003030N | Length 80 cm | Not stated | Available |
| 48003030R | Length 135 cm | Not stated | Available |
| 48004002N | Length 80 cm | Not stated | Available |
| 48004002P | Length 40 cm | Not stated | Available |
| 48004002R | Length 135 cm | Not stated | Available |
| 48004004N | Length 80 cm | Not stated | Available |
| 48004004R | Length 135 cm | Not stated | Available |
| 48004006N | Length 80 cm | Not stated | Available |
| 48004006P | Length 40 cm | Not stated | Available |
| 48004006R | Length 135 cm | Not stated | Available |
| 48004008N | Length 80 cm | Not stated | Available |
| 48004008P | Length 40 cm | Not stated | Available |
| 48004008R | Length 135 cm | Not stated | Available |
| 48004010P | Length 40 cm | Not stated | Available |
| 48004010R | Length 135 cm | Not stated | Available |
| 48004012N | Length 80 cm | Not stated | Available |
| 48004012R | Length 135 cm | Not stated | Available |
| 48004015N | Length 80 cm | Not stated | Available |
| 48004015R | Length 135 cm | Not stated | Available |
| 48004020N | Length 80 cm | Not stated | Available |
| 48004020R | Length 135 cm | Not stated | Available |
| 48004025R | Length 135 cm | Not stated | Available |
| 48004030N | Length 80 cm | Not stated | Available |
| 48004030R | Length 135 cm | Not stated | Available |
| 48005002P | Length 40 cm | Not stated | Available |
| 48005004N | Length 80 cm | Not stated | Available |
| 48005004R | Length 135 cm | Not stated | Available |
| 48005006N | Length 80 cm | Not stated | Available |
| 48005006P | Length 40 cm | Not stated | Available |
| 48005008N | Length 80 cm | Not stated | Available |
| 48005008R | Length 135 cm | Not stated | Available |
| 48005010N | Length 80 cm | Not stated | Available |
| 48005010R | Length 135 cm | Not stated | Available |
| 48005012N | Length 80 cm | Not stated | Available |
| 48005012P | Length 40 cm | Not stated | Available |
| 48005012R | Length 135 cm | Not stated | Available |
| 48005015R | Length 135 cm | Not stated | Available |
| 48005020N | Length 80 cm | Not stated | Available |
| 48005020R | Length 135 cm | Not stated | Available |
| 48005025N | Length 80 cm | Not stated | Available |
| 48005030N | Length 80 cm | Not stated | Available |
| 48005030R | Length 135 cm | Not stated | Available |
| 48006002N | Length 80 cm | Not stated | Available |
| 48006002P | Length 40 cm | Not stated | Available |
| 48006004N | Length 80 cm | Not stated | Available |
| 48006004P | Length 40 cm | Not stated | Available |
| 48006004R | Length 135 cm | Not stated | Available |
| 48006006N | Length 80 cm | Not stated | Available |
| 48006008N | Length 80 cm | Not stated | Available |
| 48006008P | Length 40 cm | Not stated | Available |
| 48006008R | Length 135 cm | Not stated | Available |
| 48006010N | Length 80 cm | Not stated | Available |
| 48006010P | Length 40 cm | Not stated | Available |
| 48006012N | Length 80 cm | Not stated | Available |
| 48006012P | Length 40 cm | Not stated | Available |
| 48006012R | Length 135 cm | Not stated | Available |
| 48006015N | Length 80 cm | Not stated | Available |
| 48006020N | Length 80 cm | Not stated | Available |
| 48006020R | Length 135 cm | Not stated | Available |
| 48006025N | Length 80 cm | Not stated | Available |
| 48006025R | Length 135 cm | Not stated | Available |
| 48006030N | Length 80 cm | Not stated | Available |
| 48006030R | Length 135 cm | Not stated | Available |
| 48007002N | Length 80 cm | Not stated | Available |
| 48007002P | Length 40 cm | Not stated | Available |
| 48007002R | Length 135 cm | Not stated | Available |
| 48007004N | Length 80 cm | Not stated | Available |
| 48007004R | Length 135 cm | Not stated | Available |
| 48007006P | Length 40 cm | Not stated | Available |
| 48007006R | Length 135 cm | Not stated | Available |
| 48007008R | Length 135 cm | Not stated | Available |
| 48007010N | Length 80 cm | Not stated | Available |
| 48007012N | Length 80 cm | Not stated | Available |
| 48007015R | Length 135 cm | Not stated | Available |
| 48007020R | Length 135 cm | Not stated | Available |
| 48007025R | Length 135 cm | Not stated | Available |
| 48007030R | Length 135 cm | Not stated | Available |
| 48008002N | Length 80 cm | Not stated | Available |
| 48008002P | Length 40 cm | Not stated | Available |
| 48008002R | Length 135 cm | Not stated | Available |
| 48008004P | Length 40 cm | Not stated | Available |
| 48008004R | Length 135 cm | Not stated | Available |
| 48008006N | Length 80 cm | Not stated | Available |
| 48008006P | Length 40 cm | Not stated | Available |
| 48008006R | Length 135 cm | Not stated | Available |
| 48008008P | Length 40 cm | Not stated | Available |
| 48008008R | Length 135 cm | Not stated | Available |
| 48008010N | Length 80 cm | Not stated | Available |
| 48008010R | Length 135 cm | Not stated | Available |
| 48009002N | Length 80 cm | Not stated | Available |
| 48009002P | Length 40 cm | Not stated | Available |
| 48009002R | Length 135 cm | Not stated | Available |
| 48009004P | Length 40 cm | Not stated | Available |
| 48009004R | Length 135 cm | Not stated | Available |
| 48009006N | Length 80 cm | Not stated | Available |
| 48009006R | Length 135 cm | Not stated | Available |
| 48009008N | Length 80 cm | Not stated | Available |
| 48009008P | Length 40 cm | Not stated | Available |
| 48009008R | Length 135 cm | Not stated | Available |
| 48009010P | Length 40 cm | Not stated | Available |
| 48009010R | Length 135 cm | Not stated | Available |
| 48010002N | Length 80 cm | Not stated | Available |
| 48010002P | Length 40 cm | Not stated | Available |
| 48010002R | Length 135 cm | Not stated | Available |
| 48010004N | Length 80 cm | Not stated | Available |
| 48010004R | Length 135 cm | Not stated | Available |
| 48010006N | Length 80 cm | Not stated | Available |
| 48010006P | Length 40 cm | Not stated | Available |
| 48010006R | Length 135 cm | Not stated | Available |
| 48010008N | Length 80 cm | Not stated | Available |
| 48010008P | Length 40 cm | Not stated | Available |
| 48010010N | Length 80 cm | Not stated | Available |
| 48010010P | Length 40 cm | Not stated | Available |
| 48010010R | Length 135 cm | Not stated | Available |
| 48012002N | Length 80 cm | Not stated | Available |
| 48012002P | Length 40 cm | Not stated | Available |
| 48012002R | Length 135 cm | Not stated | Available |
| 48012004R | Length 135 cm | Not stated | Available |
FDA clearances
- 510(k) K210626 April 2021
Procedures that use angioplasty balloons
Frequently asked questions
What is Saber .035 used for?
A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.
Who makes Saber .035?
Saber .035 is made by Cordis US Corp.. It is listed under peripheral angioplasty balloons in our device library.
What sizes does Saber .035 come in?
Sizes listed for Saber .035: Length: 40–135 cm. Confirm availability with the manufacturer's instructions for use.
Is Saber .035 MRI safe?
The FDA device database entry for Saber .035 does not state its MRI safety status. Check the labeling before MRI.
Is Saber .035 FDA cleared?
Saber .035 is covered by FDA submission K210626.
How do I contact a Cordis US Corp. sales representative?
Cordis US Corp. has not listed representatives on LA Vascular yet. Visit the Cordis US Corp. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.