The following data is part of a premarket notification filed by Thoratec Corporation with the FDA for Thoratec Centrimag Return (arterial) Cannula Kit.
| Device ID | K152161 |
| 510k Number | K152161 |
| Device Name: | Thoratec CentriMag Return (Arterial) Cannula Kit |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | Thoratec Corporation 6035 Stoneridge Drive Pleasanton, CA 94588 |
| Contact | Lori Dondiego |
| Correspondent | Lori Dondiego Thoratec Corporation 6035 Stoneridge Drive Pleasanton, CA 94588 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-03 |
| Decision Date | 2015-09-18 |
| Summary: | summary |