ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER)— 510(k) K936286

Substantially Equivalent

Gish Biomedical, Inc.

FDA 510(k) clearance K936286 for ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER), Substantially Equivalent on 1994-02-14. Applicant: Gish Biomedical, Inc..

Clearance details

Applicant: Gish Biomedical, Inc.
Product code: Code DTN
Advisory panel: Cardiovascular
Date received: 1993-11-30
Decision date: 1994-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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Adverse events under product code DTN

product code DTN

Death: 3
Total: 3

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.