K014187 is an FDA 510(k) clearance for the AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM. This device is classified as a Apparatus, Autotransfusion (Class II - Special Controls, product code CAC).
Submitted by Boehringer Laboratories (Norristown, US). The FDA issued a Cleared decision on February 6, 2002, 47 days after receiving the submission on December 21, 2001.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5830.
| 510(k) Number | K014187 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2001 |
| Decision Date | February 06, 2002 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | CAC — Apparatus, Autotransfusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5830 |