# K972512: Smash Percutaneous Transluminal Angioplasty (Pta) Cardiovascular Devices Panel

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Scimed, Inc.
- Decided: Feb 12, 1998 after 220 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 K913297 (1991). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913297: Schneider Match-35(TM) Percu Trans Angioplas Cath, Schneider Intl., Ltd. (1991) Summary page 1.
- K926271: Schneider Match-35 Percutaneous Transluminal Angio, Schneider Intl., Ltd. (1993) Summary page 1.
- K942154: Schneider Total Cross and Match 35 Percutanewous Transluminal Angioplasty Catheters, Boston Scientific Scimed, Inc. (1994) Summary page 1.

## Most influential descendants
- K021996: Bolton Pta Catheter (2002), 0 descendants of its own
- K992320: Megabello Percutaneous Transluminal Angioplasty (Pta) Catheter (2000), 0 descendants of its own

## Indications for use
The Smash™ Percutaneous Transluminal Angioplasty (PTA) Catheter is recommended for use in percutaneous dilation of the iliac, femoral, popliteal, tibial, renal, and tibioperoneal vessels in whose lumens are obstructed by atherosclerotic plaque. This catheter is not intended for use in the coronary arteries. Any other use than those indicated is not recommended.

Source page: https://510kreport.com/device/K972512
Methodology: https://510kreport.com/methodology