The following data is part of a premarket notification filed by Cobe Cardiovascular, Inc. with the FDA for Modification To: Csc14 Blood Cardioplegia System.
| Device ID | K012898 |
| 510k Number | K012898 |
| Device Name: | MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY Arvada, CO 80004 |
| Contact | Lynne Leonard |
| Correspondent | Lynne Leonard 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 | 2001-08-29 |
| Decision Date | 2001-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38033178109063 | K012898 | 000 |