# K040922: Venture Wire Control Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Velocimed, Inc.
- Decided: Aug 18, 2004 after 132 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K931794 (1994). 7 ancestors in all.
31 later devices descend from it; 2 cite it directly.
3 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012749: Biocardia Universal Deflectable Guide Catheter, Model 000664, Biocardia, Inc. (2002) Summary page 2.
- K904785: Cri Cynosar Catheter, Catheter Research C/O Burditt, Bowles & Radzius (1991) Summary page 2.
- (no number) Xtrak TOPS catheter: named in the summary without a submission number

## Most influential descendants
- K042910: Venture Wire Control Catheter, Model WCC (2004), 30 descendants of its own
- K061843: Venture Wire Control Catheter, Model WCC (2006), 28 descendants of its own
- K080987: Bridgepoint Medical Stingray Device and Accessories (2009), 24 descendants of its own
- K101591: Stingray Orienting Balloon Catheter (2010), 14 descendants of its own
- K102725: Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000, Stingray Guidewire Model M-3004 and M (2011), 11 descendants of its own

## Recalls of this device
- Apr 25, 2017 · Class I · Z-2224-2017: Vascular Solutions, Inc. (VSI) is voluntarily removing all lots of Venture catheters due to a potential problem. Venture RX (Model 5820), Venture OTW (Model 5821), and Venture CS (Model 5822) catheter

## Indications for use
The VentureTM Wire Control Catheter is indicated for directing, steering, controlling, and supporting a guide wire to access discreet regions of the coronary and peripheral vasculature. It may also be used for manual delivery of saline solution or diagnostic contrast agents.

Source page: https://510kreport.com/device/K040922
Methodology: https://510kreport.com/methodology