The following data is part of a premarket notification filed by Cardiacassist Inc. with the FDA for Tandemheart Pump.
| Device ID | K110493 |
| 510k Number | K110493 |
| Device Name: | TANDEMHEART PUMP |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | CARDIACASSIST INC. 240 ALPHA DRIVE Pittsburgh, PA 15238 |
| Contact | Robert Bollinger |
| Correspondent | Robert Bollinger CARDIACASSIST INC. 240 ALPHA DRIVE Pittsburgh, PA 15238 |
| Product Code | KFM |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-22 |
| Decision Date | 2011-09-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814112020043 | K110493 | 000 |