510(k) K120543
K120543 is an FDA 510(k) premarket notification submitted by Cardiacassist, Inc. for the device "TANDEMHEART FEMORAL ARTERIAL CANNULA SET". The FDA issued a decision of Substantially Equivalent on May 30, 2012. 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
- May 30, 2012
- Date Received
- February 23, 2012
- Clearance Type
- Traditional
- 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