# K971577: Focus-PV Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cardiovascular Dynamics, Inc.
- Decided: Jun 18, 1997 after 58 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 K944016 (1994). 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)
- K944016: Focus Balloon Dilatation Catheter, Cardiovascular Dynamics, Inc. (1994) Summary page 1.
- K952064: Focus Balloon Dilatation Catheter, Cardiovascular Dynamics, Inc. (1995) Summary page 1.
- K954313: Focus PC Balloon Dilatation Catheter, Cardio-Dynamics, Inc. (1995) Summary page 1.
- (no number) Match 35™ PTA Balloon Catheter: named in the summary without a submission number
- (no number) Total Cross™ Balloon Dilatation Catheter: named in the summary without a submission number
- (no number) MS Classique™ Balloon Dilatation Catheter: named in the summary without a submission number
- (no number) Ultra-Thin™ Balloon Dilatation Catheter: named in the summary without a submission number

## Indications for use
FOCUS™-PV Balloon Dilatation Catheters-are tecommended foi-percutaneous transluminal angioplasty of the large vessels of the renal, femoral, popliteal, tibial, peroneal, iliac and profunda arteries and for treatment of obstructive lesions of native or synthetic arterovenous dialysis fistulae.

Source page: https://510kreport.com/device/K971577
Methodology: https://510kreport.com/methodology