Submission Details
| 510(k) Number | K964070 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 10, 1996 |
| Decision Date | December 31, 1996 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Traditional
DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAG
Dec 1996
Decision
82d
Days
Class 2
Risk
About This 510(k) Submission
K964070 is an FDA 510(k) clearance for the DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAG, a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC), submitted by Deknatel, Inc. (North Attleboro, US). The FDA issued a Cleared decision on December 31, 1996, 82 days after receiving the submission on October 10, 1996. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5830.
Device Classification
| Product Code | CAC — Apparatus, Autotransfusion |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5830 |
Manufacturer
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