Angioplasty balloons
Impact
by B Braun Interventional Systems, Inc
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.
Impact 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 |
|---|---|---|---|
| 122120 | Length 120 cm | Not stated | Available |
| 124120 | — | Not stated | Available |
| 124750 | — | Not stated | Available |
| 142120 | Length 120 cm | Not stated | Available |
| 144120 | Length 120 cm | Not stated | Available |
| 144750 | Length 75 cm | Not stated | Available |
| 162750 | Length 75 cm | Not stated | Available |
| 164120 | Length 120 cm | Not stated | Available |
| 164750 | Length 75 cm | Not stated | Available |
| 182120 | Length 120 cm | Not stated | Available |
| 182750 | Length 75 cm | Not stated | Available |
| 184120 | Length 120 cm | Not stated | Available |
| 184750 | Length 75 cm | Not stated | Available |
| 202120A | Length 120 cm | Not stated | Available |
| 202750 | Length 75 cm | Not stated | Available |
| 204120 | Length 120 cm | Not stated | Available |
| 204750 | Length 75 cm | Not stated | Available |
| 222120 | Length 120 cm | Not stated | Available |
| 222750 | Length 75 cm | Not stated | Available |
| 224120 | Length 120 cm | Not stated | Available |
| 224750 | Length 75 cm | Not stated | Available |
| 252120 | Length 120 cm | Not stated | Available |
| 252750 | Length 75 cm | Not stated | Available |
| 254120 | Length 120 cm | Not stated | Available |
| 254750 | — | Not stated | Available |
FDA clearances
- 510(k) K931009 December 1993
Procedures that use angioplasty balloons
Frequently asked questions
What is Impact 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 Impact?
Impact is made by B Braun Interventional Systems, Inc. It is listed under peripheral angioplasty balloons in our device library.
What sizes does Impact come in?
Sizes listed for Impact: Length: 75–120 cm. Confirm availability with the manufacturer's instructions for use.
Is Impact MRI safe?
The FDA device database entry for Impact does not state its MRI safety status. Check the labeling before MRI.
Is Impact FDA cleared?
Impact is covered by FDA submission K931009.
How do I contact a B Braun Interventional Systems, Inc sales representative?
B Braun Interventional Systems, Inc has not listed representatives on LA Vascular yet. Visit the B Braun Interventional Systems, Inc 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.