K012763 is an FDA 510(k) clearance for the SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM. This device is classified as a Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (Class II — Special Controls, product code DRT).
Submitted by Cobe Cardiovascular, Inc. (Arvada, US). The FDA issued a Cleared decision on November 15, 2001, 90 days after receiving the submission on August 17, 2001.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.
| 510(k) Number | K012763 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 2001 |
| Decision Date | November 15, 2001 |
| Days to Decision | 90 days |
| Submission Type | Abbreviated |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRT — Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.2300 |