CARDIAC OUTPUT PULMONARY ARTERY CATHETER & MONITOR— 510(k) K925444

Substantially Equivalent

Ami-Med Corp.

FDA 510(k) clearance K925444 for CARDIAC OUTPUT PULMONARY ARTERY CATHETER & MONITOR, Substantially Equivalent on 1993-07-19. Applicant: Ami-Med Corp..

Clearance details

Applicant: Ami-Med Corp.
Product code: Code DYG
Advisory panel: Cardiovascular
Date received: 1992-10-28
Decision date: 1993-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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Adverse events under product code DYG

product code DYG

Death: 18
Malfunction: 1,051
Other: 1
Total: 1,070

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.