Angioplasty balloons
Z-Med
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.
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Where to buy Z-Med
Contact B Braun Interventional Systems, Inc directly; they can quote, ship, or point you to the distributor for your country.
From bisusa.com, checked October 2026.
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Z-Med 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 |
|---|---|---|---|
| 610235 | — | Not stated | Available |
| 610239 | — | Not stated | Available |
| 610243 | — | Not stated | Available |
| 611652 | — | Not stated | Available |
FDA clearances
- 510(k) K122012 October 2012
- 510(k) K991977 September 2000
Procedures that use angioplasty balloons
Frequently asked questions
What is Z-Med 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 Z-Med?
Z-Med is made by B Braun Interventional Systems, Inc. It is listed under peripheral angioplasty balloons in our device library.
What sizes does Z-Med come in?
The FDA device database does not list sizes for Z-Med. Check the instructions for use or ask a B Braun Interventional Systems, Inc representative.
Is Z-Med MRI safe?
The FDA device database entry for Z-Med does not state its MRI safety status. Check the labeling before MRI.
Is Z-Med FDA cleared?
Z-Med is covered by FDA submissions K122012, K991977.
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.