# K971010: Peripheral Transluminal Angioplasty Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corp.
- Decided: Jun 18, 1997 after 90 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
No predicates in its family tree.
93 later devices descend from it; 9 cite it directly.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Savvy PTA Catheters: named in the summary without a submission number
- (no number) Opta 5 PTA Catheters: named in the summary without a submission number
- (no number) Ultra Thin PTA Catheter: named in the summary without a submission number

## Most influential descendants
- K063657: Vascutrak Pta Dilation Catheter (2006), 52 descendants of its own
- K073025: Vascutrak II Pta Dilatation Catheter (2007), 48 descendants of its own
- K082343: Vascutrak 2, Models: V14 and V18 (2008), 47 descendants of its own
- K050629: Angiosculpt Scoring Balloon Catheter (2005), 38 descendants of its own
- K072225: Angiosculpt Pta Scoring Balloon Catheter (2007), 37 descendants of its own

## Indications for use
The Cordis PTA Catheters are intended for balloon dilatation of lesions in peripheral arteries (iliac, renal, popliteal, infra popliteal, femoral, and ilio femoral) and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Source page: https://510kreport.com/device/K971010
Methodology: https://510kreport.com/methodology