# K160889: BIB Stent Placement Catheter

- Pathway: 510(k) (Traditional)
- Applicant: NuMED, Inc.
- Decided: May 20, 2016 after 50 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
Longest line of descent: 2 generations back to K931009 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050857: Bib Pta Balloon Catheter, NuMED, Inc. (2005) Summary page 4.

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

Source page: https://510kreport.com/device/K160889
Methodology: https://510kreport.com/methodology