PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100)— 510(k) K963098

Substantially Equivalent

Deknatel, Inc.

FDA 510(k) clearance K963098 for PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100), Substantially Equivalent on 1996-11-08. Applicant: Deknatel, Inc..

Clearance details

Applicant: Deknatel, Inc.
Product code: Code CAC
Advisory panel: Anesthesiology
Date received: 1996-08-09
Decision date: 1996-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fall River, MA, US

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Adverse events under product code CAC

product code CAC

Death: 11
Malfunction: 477
Total: 488

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.