510(k) K094048
K094048 is an FDA 510(k) premarket notification submitted by Cardiosolutions, Inc. for the device "PERCUPRO MESSENGER BALLOON CATHETER". The FDA issued a decision of Substantially Equivalent on July 14, 2011. The device falls under product code DYG (Catheter, Flow Directed), a Class II device regulated under 21 CFR 870.1240. Cardiosolutions, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 14, 2011
- Date Received
- December 31, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Flow Directed
- Device Class
- Class II
- Regulation Number
- 870.1240
- Review Panel
- CV
- Submission Type