CROSSBOSS CATHETER MODEL M-2000, STINGRAY ORIENTING BALLOON CATHETER MODEL M-1000, STINGRAY GUIDEWIRE MODEL M-3004 AND M
FDA 510(k) clearance K102725 · decided 2011-05-10
Clearance details
- K-number
- K102725
- Device name
- CROSSBOSS CATHETER MODEL M-2000, STINGRAY ORIENTING BALLOON CATHETER MODEL M-1000, STINGRAY GUIDEWIRE MODEL M-3004 AND M
- Applicant
- Bridge Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-09-21
- Decision date
- 2011-05-10
- Days to decision
- 231 days
- Clearance type
- Traditional
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BridgePoint Medical, Stingray Catheter, REF M - 1000, Sterilized with Ethylene Oxide Gas, recall (Z-2074-2012) | Bridgepoint Medical | 2012-07-24 |