K963098

Substantially Equivalent

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

Applicant: Deknatel, Inc.
Product 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

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.