# K973563: Bipore Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Bipore, Inc.
- Decided: Apr 1, 1998 after 194 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: 2 generations back to K897106 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961980: Bipore Balloon Dilatation Catheter, Bipore, Inc. (1996) Summary page 1.

## Indications for use
The Bipore PTA catheters are indicated for percutaneous transluminal angioplasty of the iliac, femoral, and renal arteries, and for the treatment of obstructive lesions of autologous or synthetic arteriovenous dialysis fistulae. The Bipore Inc. PTA Balloon Dilatation Catheter is also indicated for post-deployed stent expansion. Use of the Bipore Dilatation Catheter for post-deployment stent expansion was demonstrated on the bench with the Cordis Palmaz™ stent*. All stents must be implanted and deployed according to the stent manufacturer's indications, contraindications, and instructions for use. Testing included: Rated Burst Pressure within the Stent Balloon Fatigue within the Stent

Source page: https://510kreport.com/device/K973563
Methodology: https://510kreport.com/methodology