# K961980: Bipore Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Bipore, Inc.
- Decided: Sep 12, 1996 after 115 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- 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: 1 generation back to K897106 (1990). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K897106: Medi-Tech Dilatation Catheters Ultra Thin II, Boston Scientific Corp (1990) Summary page 1.
- K920547: Ultra-Thin, Boston Scientific Corp (1992) Summary page 1.

## Most influential descendants
- K041293: Biopore Balloon Dilation Catheter (2004), 0 descendants of its own
- K973563: Bipore Balloon Dilatation Catheter (1998), 0 descendants of its own

## Indications for use
The Bipore Balloon Dilatation Catheter is indicated for Transluminal Percutaneous Angioplasty (PTA) of the iliac, femoral, and renal arteries, and for the treatment of obstructive lesions of autologous or synthetic arteriovenous dialysis fistulae.

Source page: https://510kreport.com/device/K961980
Methodology: https://510kreport.com/methodology