# K023463: Cvsi Peripheral Balloon Catheter; Cvsi Catheter Inflation Unit

- Pathway: 510(k) (Traditional)
- Applicant: Cryo Vascular Systems, Inc.
- Decided: Feb 19, 2003 after 127 days
- Product code: DQY (Catheter, Percutaneous)
- 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: 3 generations back to K904275 (1991). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022061: Cvsi Peripheral Balloon Catheter; Cvsi Inflater, Cryo Vascular Systems, Inc. (2002)
- K971448: Cordis Opta LP Pta Balloon Catheter, Cordis Corp. (1997) Summary page 1.

## Indications for use
The CVSiTM Peripheral Balloon Catheter and the CVSiTM Catheter Inflation Unit are indicated for percutaneous, transluminal angioplasty of stenotic lesions in the superficial femoral and popliteal arteries. The CVSiTM Peripheral Balloon Catheter System is not indicated for use in other vasculature, including coronary arteries, carotid arteries, synthetic vascular grafts, and vein grafts. The CVSiTM Peripheral Balloon Catheter System is not indicated for stent delivery or stent expansion.

Source page: https://510kreport.com/device/K023463
Methodology: https://510kreport.com/methodology