# K083139: Vipersphere Pta  Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cardiovascular Systems, Inc.
- Decided: Nov 25, 2008 after 33 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: 4 generations back to K001134 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993913: TRUE, Infinity Extrusion & Engineering, Inc. (2000) Summary page 1.
- K053116: Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx, Boston Scientific Corp (2005) Summary page 1.
- K971010: Peripheral Transluminal Angioplasty Catheters, Cordis Corp. (1997) Summary page 1.
- K052791: Modification to: Amphirion Deep 0.014 Otw Pta Balloon Catheter, Invatec Innovative Technologies, S.R.L. (2005) Summary page 1.

## Indications for use
The ViperSphere PTA balloon dilatation catheter is intended to dilate stenoses in peripheral arteries including the iliac, femoral, popliteal, and infra-popliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Source page: https://510kreport.com/device/K083139
Methodology: https://510kreport.com/methodology