510(k) K111488
K111488 is an FDA 510(k) premarket notification submitted by Bridgepoint Medical for the device "MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003". The FDA issued a decision of Substantially Equivalent on June 30, 2011. 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
- June 30, 2011
- Date Received
- May 31, 2011
- 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