# K963688: Focus PV Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cardiovascular Dynamics, Inc.
- Decided: Mar 28, 1997 after 193 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 Catheters: 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
The FOCUS™-PV Balloon Dilatation Catheter is a balloon dilatation catheter intended for use in percutaneous transluminal balloon dilatation (PTA) of large vessels of the peripheral vasculature.

Source page: https://510kreport.com/device/K963688
Methodology: https://510kreport.com/methodology