The following data is part of a premarket notification filed by Cardiac Assist, Inc. with the FDA for Tandemheart Transseptal Cannula Set-ef, Model 5140-6221.
| Device ID | K052570 |
| 510k Number | K052570 |
| Device Name: | TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221 |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | CARDIAC ASSIST, INC. 240 ALPHA DR. Pittsburgh, PA 15238 |
| Contact | Tim Krauskopf |
| Correspondent | Tim Krauskopf CARDIAC ASSIST, INC. 240 ALPHA DR. 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 | 2005-09-19 |
| Decision Date | 2006-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814112020395 | K052570 | 000 |
| 00814112020371 | K052570 | 000 |
| 00814112020364 | K052570 | 000 |
| 00814112020234 | K052570 | 000 |
| 00814112020128 | K052570 | 000 |
| 00814112020067 | K052570 | 000 |
| 00814112020036 | K052570 | 000 |