510(k) K926338
K926338 is an FDA 510(k) premarket notification submitted by Deknatel, Inc. for the device "PLEUR-EVAC CARDIOTOMY RESERVOIR # CR-9400 & 9400F". The FDA issued a decision of Substantially Equivalent on Jul 26, 1994. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Deknatel, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 26, 1994
- Date Received
- Dec 18, 1992
- 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