# K983650: Bipore Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Bipore, Inc.
- Decided: Feb 17, 1999 after 124 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
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. The FDA summary names its predicate without a number.
- (no number) Bipore Balloon Dilatation Catheter: named in the summary without a submission number

## Indications for use
The Bipore Balloon Dilatation Catheter is recommended 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 PTA Balloon Dilatation Catheter is also indicated for post deployed stent expansion. Use of the Bipore Balloon Dilatation Catheter for post-deployed stent expansion was demonstrated on the bench with the Cordis Palmaz™ stent*. *Testing included: Rated Burst Pressure within the stent Balloon Fatigue within the stent

Source page: https://510kreport.com/device/K983650
Methodology: https://510kreport.com/methodology