Angioplasty balloons
Sleek OTW PTA Dilatation Catheter
by Clearstream Technologies Limited
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.
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Where to buy Sleek OTW PTA Dilatation Catheter
We do not have contact details for Clearstream Technologies Limited yet. Send a request and we will route it to the right person for your country.
Sleek OTW PTA Dilatation Catheter 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 |
|---|---|---|---|
| 426-1201X | — | Not stated | Available |
| 426-1501X | — | Not stated | Available |
| 426-1502X | — | Not stated | Available |
| 426-1504X | — | Not stated | Available |
| 426-1508X | — | Not stated | Available |
| 426-1510X | — | Not stated | Available |
| 426-1512X | — | Not stated | Available |
| 426-2002X | — | Not stated | Available |
| 426-2004X | — | Not stated | Available |
| 426-2008X | — | Not stated | Available |
| 426-2010X | — | Not stated | Available |
| 426-2012X | — | Not stated | Available |
| 426-2015X | — | Not stated | Available |
| 426-2022X | — | Not stated | Available |
| 426-2028X | — | Not stated | Available |
| 426-2502X | — | Not stated | Available |
| 426-2504X | — | Not stated | Available |
| 426-2508X | — | Not stated | Available |
| 426-2510X | — | Not stated | Available |
| 426-2512X | — | Not stated | Available |
| 426-2515X | — | Not stated | Available |
| 426-2522X | — | Not stated | Available |
| 426-2528X | — | Not stated | Available |
| 426-3002X | — | Not stated | Available |
| 426-3004X | — | Not stated | Available |
| 426-3008X | — | Not stated | Available |
| 426-3010X | — | Not stated | Available |
| 426-3012X | — | Not stated | Available |
| 426-3015X | — | Not stated | Available |
| 426-3022X | — | Not stated | Available |
| 426-3028X | — | Not stated | Available |
| 426-3502X | — | Not stated | Available |
| 426-3504X | — | Not stated | Available |
| 426-3508X | — | Not stated | Available |
| 426-3510X | — | Not stated | Available |
| 426-3512X | — | Not stated | Available |
| 426-3515X | — | Not stated | Available |
| 426-3522X | — | Not stated | Available |
| 426-3528X | — | Not stated | Available |
| 426-4002X | — | Not stated | Available |
| 426-4004X | — | Not stated | Available |
| 426-4008X | — | Not stated | Available |
| 426-4010X | — | Not stated | Available |
| 426-4012X | — | Not stated | Available |
| 426-4015X | — | Not stated | Available |
| 426-4022X | — | Not stated | Available |
| 426-4028X | — | Not stated | Available |
| 426-5002X | — | Not stated | Available |
| 426-5004X | — | Not stated | Available |
| 426-5008X | — | Not stated | Available |
| 426-5010X | — | Not stated | Available |
| 426-5012X | — | Not stated | Available |
| 426-5015X | — | Not stated | Available |
| 426-5022X | — | Not stated | Available |
| 426-5028X | — | Not stated | Available |
FDA clearances
- 510(k) K130786 May 2013
- 510(k) K102035 December 2010
Procedures that use angioplasty balloons
Frequently asked questions
What is Sleek OTW PTA Dilatation Catheter 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 Sleek OTW PTA Dilatation Catheter?
Sleek OTW PTA Dilatation Catheter is made by Clearstream Technologies Limited. It is listed under peripheral angioplasty balloons in our device library.
What sizes does Sleek OTW PTA Dilatation Catheter come in?
The FDA device database does not list sizes for Sleek OTW PTA Dilatation Catheter. Check the instructions for use or ask a Clearstream Technologies Limited representative.
Is Sleek OTW PTA Dilatation Catheter MRI safe?
The FDA device database entry for Sleek OTW PTA Dilatation Catheter does not state its MRI safety status. Check the labeling before MRI.
Is Sleek OTW PTA Dilatation Catheter FDA cleared?
Sleek OTW PTA Dilatation Catheter is covered by FDA submissions K130786, K102035.
How do I contact a Clearstream Technologies Limited sales representative?
Clearstream Technologies Limited has not listed representatives on LA Vascular yet. Visit the Clearstream Technologies Limited 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.