ACCESS. KIT FOR THE BIOSURGE SYNCHRONOUS AUTOTRANS— 510(k) K902713

Name: FDA 510(k) clearance K902713
Creator: U.S. Food and Drug Administration
Published: 1990-07-25

Substantially Equivalent

Diemolding Corp.

FDA 510(k) clearance K902713 for ACCESS. KIT FOR THE BIOSURGE SYNCHRONOUS AUTOTRANS, Substantially Equivalent on 1990-07-25. Applicant: Diemolding Corp.. Device class: 2.

Clearance details

Applicant: Diemolding Corp.
Product code: Code CAC
Device class: Class 2
Regulation: 21 CFR 868.5830
Advisory panel: Anesthesiology
Date received: 1990-06-20
Decision date: 1990-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canastota, NY, US

Download summary PDF View on FDA.gov ↗

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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.