The following data is part of a premarket notification filed by Cobe Cardiovascular, Inc. with the FDA for Sorin Biomedica Smarxt Bcd Vanguard Surface Modified Cardioplegia System.
| Device ID | K021830 |
| 510k Number | K021830 |
| Device Name: | SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY Arvada, CO 80004 |
| Contact | Shawn Riedel |
| Correspondent | Shawn Riedel COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY Arvada, CO 80004 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-04 |
| Decision Date | 2002-07-02 |
| Summary: | summary |