# K993913: TRUE

- Pathway: 510(k) (Traditional)
- Applicant: Infinity Extrusion & Engineering, Inc.
- Decided: Aug 9, 2000 after 266 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Smash™ PTA Catheter: named in the summary without a submission number

## Most influential descendants
- K083139: Vipersphere Pta  Balloon Catheter (2008), 0 descendants of its own

## Indications for use
Intended for Percutaneous Dilatation of the iliac, femoral, popliteal, tibial, renal, infra popliteal, ilio femoral, and tibiopernoeal arteries.

Source page: https://510kreport.com/device/K993913
Methodology: https://510kreport.com/methodology