# K970725: Opti-Plast XL 5.5 F Pta Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Vas-Cath, Inc.
- Decided: May 9, 1997 after 70 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 K933483 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933483: Opti-Plast 5F Pta Catheters, Vas-Cath, Inc. (1993) Summary page 1.
- K952063: XXL Ballon Dilatation Catheter, Boston Scientific Corp (1995) Summary page 1.

## Indications for use
The Opti-Plast® XL 5.5 F PTA Catheter is reccommended for use in the Percutaneous Transluminal Angioplasty of the Iliac and Femoral vessels. This catheter is not for use in coronary arteries. The device is indicated for single use only and indicated not to be resterilized nor reused.

Source page: https://510kreport.com/device/K970725
Methodology: https://510kreport.com/methodology