BIOSURGE(TM) SYNCHRONOUS AUTOTRANS PROCEDURE KIT— 510(k) K931106

Substantially Equivalent

Deknatel, Inc.

FDA 510(k) clearance K931106 for BIOSURGE(TM) SYNCHRONOUS AUTOTRANS PROCEDURE KIT, Substantially Equivalent on 1993-10-06. Applicant: Deknatel, Inc..

Clearance details

Applicant: Deknatel, Inc.
Product code: Code CAC
Advisory panel: Anesthesiology
Date received: 1993-03-03
Decision date: 1993-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose-Heredia, CR

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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.