510(k) K133293
K133293 is an FDA 510(k) premarket notification submitted by Cardiacassist, Inc. for the device "15 FR. TANDEMHEART ARTERIAL CANNULA". The FDA issued a decision of Substantially Equivalent on February 12, 2014. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. Cardiacassist, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 12, 2014
- Date Received
- October 25, 2013
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4210
- Review Panel
- CV
- Submission Type