# K080987: Bridgepoint Medical Stingray Device and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Bridgepoint Medical
- Decided: Feb 6, 2009 after 305 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K931794 (1994). 22 ancestors in all.
24 later devices descend from it; 4 cite it directly.
3 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011562: Lumend Percutaneous Catheter, Lumend, Inc. (2002) Summary page 1.
- K061843: Venture Wire Control Catheter, Model WCC, St Jude Medical (2006) Summary page 1.
- K041151: Kerberos Occluding Guide Catheter and Accessories, Kerberos Proximal Solutions, Inc. (2004) Summary page 1.

## Most influential descendants
- 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
- K111963: Bridgepoint Medical Mantaray (TM) Catheter (2011), 7 descendants of its own
- K120129: Mantaray Catheter (2012), 6 descendants of its own

## Recalls of this device
- Jun 26, 2012 · Class II · Z-2074-2012: BridgePoint Medical Inc. is voluntarily recalling Stingray Catheter, Model M1000 lots BP20121440078 and BP20121560089. BridgePoint Medical, Inc. recently determined the potential of compromised steril

## Indications for use
The BridgePoint Medical StingrayTM Orienting Balloon Catheters are indicated for directing, steering, controlling, and supporting a guidewire in order to access discrete regions of the coronary and peripheral vasculature.

Source page: https://510kreport.com/device/K080987
Methodology: https://510kreport.com/methodology