# K042910: Venture Wire Control Catheter, Model WCC

- Pathway: 510(k) (Special)
- Applicant: Velocimed, Inc.
- Decided: Nov 22, 2004 after 32 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K931794 (1994). 8 ancestors in all.
30 later devices descend from it; 3 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)
- K040922: Venture Wire Control Catheter, Velocimed, Inc. (2004) Summary page 2.

## Most influential descendants
- 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
- K121763: Multicross Support Catheter (2012), 8 descendants of its own

## Recalls of this device
- Mar 7, 2018 · Class II · Z-3041-2018: The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
- 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/K042910
Methodology: https://510kreport.com/methodology