510(k) K083727
K083727 is an FDA 510(k) premarket notification submitted by Bridgepoint Medical for the device "STINGRAY GUIDEWIRE, STIFF, MODELS M-3003, M-3004, M-3011, M-3012". The FDA issued a decision of Substantially Equivalent on February 20, 2009. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Bridgepoint Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 20, 2009
- Date Received
- December 15, 2008
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wire, Guide, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1330
- Review Panel
- CV
- Submission Type