BIB Stent Placement Catheter
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by NuMED, Inc.
Identifiers
- 510(k) Number
- K213915 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
- SESE Substantially Equivalent FDA 510(k)
The BIB Stent Placement Catheter is a dual-balloon angioplasty catheter designed for peripheral transluminal stent placement. It facilitates incremental and controlled expansion of stents within blood vessels, ensuring even deployment and precise positioning.
This device is supplied as a single-use, non-sterile catheter with outer and inner balloons measuring 12mm to 30mm in diameter. The inner balloon, half the diameter of the outer balloon and 1.0 cm shorter, acts as a positioning tool during stent expansion. It is intended for use in cardiovascular procedures and has received FDA 510(k) clearance under the Special 510(k) program, complying with the Medical Device Directive (MDD).
Frequently asked questions
What is the primary purpose of the BIB Stent Placement Catheter in medical procedures?
The BIB Stent Placement Catheter is specifically designed for peripheral transluminal stent placement in blood vessels. Its dual-balloon system allows for incremental and controlled expansion of stents, ensuring even deployment and precise positioning within the vessel during cardiovascular procedures.
How are the inner and outer balloons of the BIB Stent Placement Catheter sized and what is their purpose?
The catheter features an outer balloon ranging from 12mm to 30mm in diameter and an inner balloon that is half the diameter of the outer balloon and 1.0 cm shorter. The inner balloon serves as a positioning tool to assist in accurately placing and expanding the stent within the vessel during the procedure.
Is the BIB Stent Placement Catheter intended for single-use or repeated use, and what are its sterility specifications?
The BIB Stent Placement Catheter is supplied as a single-use device and is non-sterile at the time of shipment. It is not designed for reuse, so proper sterilization or reprocessing is not applicable.
What regulatory pathway was followed for the FDA clearance of this device, and which committee reviewed it?
The BIB Stent Placement Catheter received FDA clearance under the Special 510(k) program, with a decision classified as Substantially Equivalent (SESE). The review was conducted by the Cardiovascular (CV) Advisory Committee, reflecting its classification under the Medical Device Directive (MDD) and its intended use in cardiovascular procedures.
What size range of vessels can the BIB Stent Placement Catheter accommodate during stent placement?
The catheter’s outer balloon ranges from 12mm to 30mm in diameter, making it suitable for stent placement in larger peripheral blood vessels. The inner balloon’s smaller size (half the outer balloon’s diameter) aids in precise positioning within the vessel lumen.
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® Stent Placement Balloon Catheter | NuMED For Children, BIB® (Balloon in Balloon) Catheter - bisusa.com, Stent Placement 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 | K213915 | Class II | Active |
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Manufacturer
- Manufacturer
- NuMED, Inc.
Sources (2)
- FDA 510(k) K213915 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 28, 2026