The following data is part of a premarket notification filed by Cardiacassist Inc. with the FDA for Tandemheart Femoral Arterial Cannula Set.
| Device ID | K120543 |
| 510k Number | K120543 |
| Device Name: | TANDEMHEART FEMORAL ARTERIAL CANNULA SET |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | CARDIACASSIST INC. 240 ALPHA DRIVE Pittsburgh, PA 15238 |
| Contact | Katie Dillon |
| Correspondent | Katie Dillon CARDIACASSIST INC. 240 ALPHA DRIVE Pittsburgh, PA 15238 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-23 |
| Decision Date | 2012-05-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814112020104 | K120543 | 000 |