# K102725: Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000, Stingray Guidewire Model M-3004 and M

- Pathway: 510(k) (Traditional)
- Applicant: Bridge Medical, Inc.
- Decided: May 10, 2011 after 231 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: 8 generations back to K890505 (1989). 53 ancestors in all.
11 later devices descend from it; 5 cite it directly.
3 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013284: Lumend Frontrunner Cto Coronary Catheter, Lumend, Inc. (2002) Summary page 1.
- K023223: Modification to Lumend Frontrunner Cto Catheter, Lumend, Inc. (2002) Summary page 1.
- K023114: Lumend Frontrunner Cto Catheter, Lumend, Inc. (2003) Summary page 1.
- K031005: Lumend Frontrunner GW Cto Catheter, Lumend, Inc. (2003)
- K033535: Lumend Frontrunner Cto Catheter and Accessories, Lumend, Inc. (2004) Summary page 1.
- K081130: Bridgepoint Medical Crossboss Percutaneous Coronary Catheter, Bridgepoint Medical (2009) Summary page 1.
- K091841: Bridgepoint Medical Crossboss Catheter, Model M-2000, Bridgepoint Medical (2009) Summary page 1.
- K080987: Bridgepoint Medical Stingray Device and Accessories, Bridgepoint Medical (2009) Summary page 1.
- K101591: Stingray Orienting Balloon Catheter, Bridgepoint Medical (2010) Summary page 1.
- K081187: Bridgepoint Medical Entera Percutaneous Coronary and Peripheral Guidewire, Model M-3001, Bridgepoint Medical (2008) Summary page 1.
- K083727: Stingray Guidewire, Stiff, Models M-3003, M-3004, M-3011, M-3012, Bridgepoint Medical (2009) Summary page 1.

## Most influential descendants
- 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
- K152401: Stingray LP Catheter (2015), 1 descendant of its own
- K262013: Kiba CTO Crossing Catheter (2026), 0 descendants of its own
- K231176: Stingray LP Catheter (2023), 0 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 System (consisting of the CrossBoss™ Catheter, Stingray™ Orienting Balloon Catheter, and Stingray™ Guidewire) is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions) prior to PTCA or stent intervention.

Source page: https://510kreport.com/device/K102725
Methodology: https://510kreport.com/methodology