510(k) K014187
K014187 is an FDA 510(k) premarket notification submitted by Boehringer Laboratories for the device "AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM". The FDA issued a decision of Substantially Equivalent on February 6, 2002. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Boehringer Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 6, 2002
- Date Received
- December 21, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Autotransfusion
- Device Class
- Class II
- Regulation Number
- 868.5830
- Review Panel
- CV
- Submission Type