# K101591: Stingray Orienting Balloon Catheter

- Pathway: 510(k) (Special)
- Applicant: Bridgepoint Medical
- Decided: Aug 6, 2010 after 60 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: 7 generations back to K931794 (1994). 23 ancestors in all.
14 later devices descend from it; 2 cite it directly.
3 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080987: Bridgepoint Medical Stingray Device and Accessories, Bridgepoint Medical (2009) Summary page 1.

## Most influential descendants
- 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
- K111963: Bridgepoint Medical Mantaray (TM) Catheter (2011), 7 descendants of its own
- K120129: Mantaray Catheter (2012), 6 descendants of its own
- K120533: Bigboss Catheters Mantatay Catheter Mantaray Guidewires (2012), 5 descendants of its own
- K193596: Wingman 14, Wingman 14C, Wingman 18, Wingman 35 (2020), 1 descendant 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 Catheter is indicated for directing, steering, controlling, and supporting a guidewire in order to access discrete regions of the coronary and peripheral vaseulature

Source page: https://510kreport.com/device/K101591
Methodology: https://510kreport.com/methodology