# K161451: BIB Stent Placement Catheter

- Pathway: 510(k) (Traditional)
- Applicant: NuMED, Inc.
- Decided: Sep 22, 2016 after 119 days
- Product code: NVM (Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Indicated for CP Stent / Covered CP Stent placement in vessels over 8mm in diameter.

Source page: https://510kreport.com/device/K161451
Methodology: https://510kreport.com/methodology