510(k) K113589
K113589 is an FDA 510(k) premarket notification submitted by Bridgepoint Medical for the device "BIGBOSS CATHETER". The FDA issued a decision of Substantially Equivalent on January 4, 2012. 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
- January 4, 2012
- Date Received
- December 5, 2011
- 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