The following data is part of a premarket notification filed by Cobe Cardiovascular, Inc. with the FDA for Sorin Biomedica Smart Bcd Vanguard,surface Modified Blood Cardioplegia System.
| Device ID | K012763 |
| 510k Number | K012763 |
| Device Name: | SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| 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 | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-17 |
| Decision Date | 2001-11-15 |
| Summary: | summary |