The following data is part of a premarket notification filed by Boehringer Laboratories with the FDA for Autovac Orthopedic Autotransfusion System.
| Device ID | K014187 |
| 510k Number | K014187 |
| Device Name: | AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM |
| Classification | Apparatus, Autotransfusion |
| Applicant | BOEHRINGER LABORATORIES 500 E. WASHINGTON ST. Norristown, PA 19401 |
| Contact | John Karpowicz |
| Correspondent | John Karpowicz BOEHRINGER LABORATORIES 500 E. WASHINGTON ST. Norristown, PA 19401 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-21 |
| Decision Date | 2002-02-06 |