510(k) K152161
K152161 is an FDA 510(k) premarket notification submitted by Thoratec Corporation for the device "Thoratec CentriMag Return (Arterial) Cannula Kit". The FDA issued a decision of Substantially Equivalent on September 18, 2015. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. Thoratec Corporation has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 18, 2015
- Date Received
- August 3, 2015
- 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