# Bridgepoint Medical

- Location (FDA's records): Plymouth, MN
- FDA decisions: 14 (2008–2012): 14 510(k) clearances
- Product codes: DQY (7), DQX (6), PDU (1)
- Predicates its devices cite: 29 (17 its own); citations of its devices by later devices: 27 (17 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Asahi Intecc Co., Ltd.: 3 (https://510kreport.com/company/asahi-intecc)
- Lumend, Inc.: 2 (https://510kreport.com/company/lumend)
- Bridge Medical, Inc.: 2 (https://510kreport.com/company/bridge-medical)
- St Jude Medical: 1 (https://510kreport.com/company/st-jude-medical)
- Kerberos Proximal Solutions, Inc.: 1 (https://510kreport.com/company/kerberos-proximal-solutions)
- Lake Region Mfg., Inc.: 1 (https://510kreport.com/company/lake-region-mfg)
- Brivant, Ltd.: 1 (https://510kreport.com/company/brivant)
- Schneider Intl., Ltd.: 1 (https://510kreport.com/company/schneider-intl)

## Firms that cite its devices most
- Bridge Medical, Inc.: 6 (https://510kreport.com/company/bridge-medical)
- Roxwood Medical, Inc.: 1 (https://510kreport.com/company/roxwood-medical)
- Xablecath, Inc.: 1 (https://510kreport.com/company/xablecath)
- Reflow Medical, Inc.: 1 (https://510kreport.com/company/reflow-medical)
- Tractus Vascular, LLC: 1 (https://510kreport.com/company/tractus-vascular)

## Its most-cited devices
- K080987: Bridgepoint Medical Stingray Device and Accessories (2009), cited by 4
- K120533: Bigboss Catheters Mantatay Catheter Mantaray Guidewires (2012), cited by 4
- K081187: Bridgepoint Medical Entera Percutaneous Coronary and Peripheral Guidewire, Model M-3001 (2008), cited by 3
- K081130: Bridgepoint Medical Crossboss Percutaneous Coronary Catheter (2009), cited by 3
- K101591: Stingray Orienting Balloon Catheter (2010), cited by 2
- K111963: Bridgepoint Medical Mantaray (TM) Catheter (2011), cited by 2

## Recent decisions
- K122795: Stingray Guidewires (Nov 8, 2012)
- K121745: Mantaray Guidewires (Jul 13, 2012)
- K120533: Bigboss Catheters Mantatay Catheter Mantaray Guidewires (May 22, 2012)
- K120881: Mantaray Guidewires (Apr 18, 2012)
- K120129: Mantaray Catheter (Feb 3, 2012)
- K113589: Bigboss Catheter (Jan 4, 2012)
- K111963: Bridgepoint Medical Mantaray (TM) Catheter (Aug 10, 2011)
- K111488: Mantaray Guidewire Model M-6000, M-6001, M-6002, M-6003 (Jun 30, 2011)

Source page: https://510kreport.com/company/bridgepoint-medical