# K041293: Biopore Balloon Dilation Catheter

- Pathway: 510(k) (Abbreviated)
- Applicant: Bipore, Inc.
- Decided: Jul 9, 2004 after 56 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 Balloon Dilation Catheter is intended to be used for percutaneous transluminal angioplasty of the iliac, femoral and renal arteries, and for the treatment of obstructive lesions of the autologous or synthetic arteriovenous dialysis fistulae.

Source page: https://510kreport.com/device/K041293
Methodology: https://510kreport.com/methodology