# K022061: Cvsi Peripheral Balloon Catheter; Cvsi Inflater

- Pathway: 510(k) (Traditional)
- Applicant: Cryo Vascular Systems, Inc.
- Decided: Sep 20, 2002 after 87 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: 2 generations back to K904275 (1991). 5 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944016: Focus Balloon Dilatation Catheter, Cardiovascular Dynamics, Inc. (1994) Summary page 1.
- K971448: Cordis Opta LP Pta Balloon Catheter, Cordis Corp. (1997) Summary page 1.
- K896849: Acs Indeflator XX, Advanced Cardiovascular Systems, Inc. (1990) Summary page 1.
- K953676: Breeze Digital Inflation Device, Namic (1996) Summary page 1.

## Most influential descendants
- K040155: Peripheral Cutting Balloon (2004), 6 descendants of its own
- K051254: Peripheral Cutting Balloon (2005), 5 descendants of its own
- K041993: 2 CM Peripheral Cutting Baloon (2004), 5 descendants of its own
- K052038: Peripheral Cutting Balloon Small Monorail or Over-the-Wire Delivery System (2005), 4 descendants of its own
- K062387: Small Peripheral Cutting Ballon, Monorail Delivery System (2006), 3 descendants of its own

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

Source page: https://510kreport.com/device/K022061
Methodology: https://510kreport.com/methodology