The following data is part of a premarket notification filed by Cardiac Assist, Inc. with the FDA for Cardiacassist Transseptal Cannula Set, Model 5132-6221.
| Device ID | K030398 |
| 510k Number | K030398 |
| Device Name: | CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221 |
| Classification | Cannula, Catheter |
| 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 | DQR |
| CFR Regulation Number | 870.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-06 |
| Decision Date | 2003-05-23 |
| Summary: | summary |