The following data is part of a premarket notification filed by Cardiacassist Inc. with the FDA for 15 Fr. Tandemheart Arterial Cannula.
| Device ID | K133293 |
| 510k Number | K133293 |
| Device Name: | 15 FR. TANDEMHEART ARTERIAL CANNULA |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | CARDIACASSIST INC. 240 ALPHA DRIVE Pittsburgh, PA 15238 |
| Contact | Greg Johnson |
| Correspondent | Greg Johnson CARDIACASSIST INC. 240 ALPHA DRIVE Pittsburgh, PA 15238 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-25 |
| Decision Date | 2014-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814112020111 | K133293 | 000 |