510(k) K112404
K112404 is an FDA 510(k) premarket notification submitted by Concentric Medical, Inc. for the device "CONCENTRIC BALLOON GUIDE CATHETER". The FDA issued a decision of Substantially Equivalent on March 15, 2012. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Concentric Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 15, 2012
- Date Received
- August 22, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type