510(k) K093801
K093801 is an FDA 510(k) premarket notification submitted by Abiomed, Inc. for the device "IMPELLA CONTROLLER". The FDA issued a decision of Substantially Equivalent on July 8, 2010. The device falls under product code KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type), a Class II device regulated under 21 CFR 870.4360. Abiomed, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 8, 2010
- Date Received
- December 10, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- Device Class
- Class II
- Regulation Number
- 870.4360
- Review Panel
- CV
- Submission Type