BIB PTA Balloon Catheter
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by NuMED, Inc.
Identifiers
- 510(k) Number
- K050857 FDA 510(k)
- FDA Product Code
- NVM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESU FDA 510(k)
The BIB PTA Balloon Catheter is a dual-balloon angioplasty device designed for percutaneous transluminal angioplasty (PTA) of peripheral arteries. It features an inner balloon with half the diameter of the outer balloon and is 1.0 cm shorter in length, enabling targeted dilation of stenotic or occluded segments in the femoral, iliac, and renal arteries.
This device is supplied as a single-use catheter in sizes of 8.0 and 10.0 cm diameters with lengths ranging from 2.5 to 5.5 cm. It is intended for use in interventional cardiology procedures and is classified as a Class II medical device under FDA regulations (K050857, NVM). Sterility and regulatory compliance are ensured through FDA 510(k) clearance and adherence to the Medical Device Directive (MDD)
Frequently asked questions
What types of arteries is the BIB PTA Balloon Catheter specifically designed to treat, and how does its dual-balloon design help in these procedures?
The BIB PTA Balloon Catheter is designed for percutaneous transluminal angioplasty (PTA) of peripheral arteries, including the femoral, iliac, and renal arteries. Its dual-balloon design—featuring an inner balloon with half the diameter of the outer balloon and 1.0 cm shorter length—allows for targeted dilation of stenotic or occluded segments. This enables precise treatment of specific areas within these arteries, improving control over dilation depth and pressure application.
Is the BIB PTA Balloon Catheter intended for reuse, or is it meant to be used only once per patient?
The BIB PTA Balloon Catheter is explicitly supplied as a single-use device. This design ensures sterility and safety for one-time use per patient, reducing the risk of contamination or cross-infection between procedures.
What sizes are available for the BIB PTA Balloon Catheter, and how might a clinician choose between them?
The catheter is available in two diameter sizes—8.0 mm and 10.0 mm—with lengths ranging from 2.5 cm to 5.5 cm. The choice depends on the specific anatomy and severity of stenosis in the femoral, iliac, or renal arteries. Larger diameters (10.0 mm) may be preferred for more significant blockages, while shorter lengths (2.5 cm) could be better suited for confined or delicate areas requiring precision.
How is sterility maintained for the BIB PTA Balloon Catheter, and what storage instructions should be followed?
Sterility is ensured through FDA 510(k) clearance and adherence to the Medical Device Directive (MDD). The catheter should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Once opened, it must be used immediately to prevent contamination, as it is a single-use device.
What regulatory pathways does the BIB PTA Balloon Catheter follow, and which advisory committee was involved in its review?
The device follows the FDA 510(k) clearance pathway and is classified as a Class II medical device under FDA regulations (K050857). Its review was handled by the Cardiovascular (CV) Advisory Committee, which evaluates peripheral angioplasty devices for safety and effectiveness in interventional cardiology procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BIB® PTA Balloon Catheter - NuMED For Children, BIB® Stent Placement Balloon Catheter | NuMED For Children, BIB® (Balloon in Balloon) Catheter - bisusa.com
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K050857 | Class II | Active |
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Manufacturer
- Manufacturer
- NuMED, Inc.
Sources (2)
- FDA 510(k) K050857 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026