# K050857: Bib Pta Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: NuMED, Inc.
- Decided: Jul 28, 2005 after 114 days
- Product code: NVM (Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K931009 (1993). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931009: Tyshak Peripheral Balloon Dilation Catheter, NuMED, Inc. (1993) Summary page 1.

## Most influential descendants
- K160889: BIB Stent Placement Catheter (2016), 0 descendants of its own

## Recalls of this device
- Apr 21, 2025 · Class II · Z-1754-2025: Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer balloon inflation hub was labeled as the inner balloon

## Indications for use
This device is labeled for Percutaneous Transluminal Angioplasty (PTA) if the femoral, iliac and renal arteries. These catheters are not designed to be used in the coronary arteries.

Source page: https://510kreport.com/device/K050857
Methodology: https://510kreport.com/methodology