510(k) K101591
K101591 is an FDA 510(k) premarket notification submitted by Bridgepoint Medical for the device "STINGRAY ORIENTING BALLOON CATHETER". The FDA issued a decision of Substantially Equivalent on August 6, 2010. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Bridgepoint Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 6, 2010
- Date Received
- June 7, 2010
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type