The following data is part of a premarket notification filed by Cardiac Assist, Inc. with the FDA for Tandemlung Oxygenator.
| Device ID | K153295 |
| 510k Number | K153295 |
| Device Name: | TandemLung Oxygenator |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | CARDIAC ASSIST, INC. 240 ALPHA DR. Pittsburgh, PA 15238 |
| Contact | Greg Johnson |
| Correspondent | Greg Johnson CARDIAC ASSIST, INC. 240 ALPHA DR. Pittsburgh, PA 15238 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-13 |
| Decision Date | 2016-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814112020241 | K153295 | 000 |
| 00814112020609 | K153295 | 000 |