# K973013: Opti-Plast (Centurion) 5.5F Angioplasty Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Vas-Cath, Inc.
- Decided: Jun 19, 1998 after 310 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.
13 later devices descend from it; 2 cite it directly.
0 of 16 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.
- K934191: New Blue Max Balloon Dilatation Catheter, Boston Scientific Corp (1993) Summary page 1.

## Most influential descendants
- K040243: Bard Atlas Pta Balloon Dilatation Catheter (2004), 11 descendants of its own
- K052236: Bard Atlas Pta Balloon Dilatation Catheter (2005), 10 descendants of its own
- K120971: Atlas Pta Balloon Dilatation Catheter (2012), 9 descendants of its own
- K122984: Atlas Gold Pta Dilatation Catheter (2012), 7 descendants of its own
- K122367: Bard PTV Dilatation Catheter (2012), 5 descendants of its own

## Indications for use
Centurion Peripheral Balloon Dilatation Catheters are recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries, post-deployment dilatation of peripheral vascular stents and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The catheter is not for use in coronary arteries.

Source page: https://510kreport.com/device/K973013
Methodology: https://510kreport.com/methodology