510(k) K915130
K915130 is an FDA 510(k) premarket notification submitted by Estracorporeal, Inc. for the device "MAT MEMBRANE AUTOTRANSFUSION SYSTEM". The FDA issued a decision of Substantially Equivalent on February 22, 1993. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Estracorporeal, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 22, 1993
- Date Received
- November 13, 1991
- 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