The following data is part of a premarket notification filed by Cardiac Assist, Inc. with the FDA for Tandemheart Transseptal Cannula- Ef 72.
| Device ID | K082425 |
| 510k Number | K082425 |
| Device Name: | TANDEMHEART TRANSSEPTAL CANNULA- EF 72 |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | CARDIAC ASSIST, INC. 240 ALPHA DR. Pittsburgh, PA 15238 |
| Contact | Robert Bollinger |
| Correspondent | Robert Bollinger CARDIAC ASSIST, INC. 240 ALPHA DR. 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 | 2008-08-22 |
| Decision Date | 2008-09-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814112020388 | K082425 | 000 |
| 00814112020098 | K082425 | 000 |