SWAN-GANZ VIP THERMODILUTION CATHETER— 510(k) K810124

Substantially Equivalent

American Edwards Laboratories

FDA 510(k) clearance K810124 for SWAN-GANZ VIP THERMODILUTION CATHETER, Substantially Equivalent on 1981-02-04. Applicant: American Edwards Laboratories.

Clearance details

Applicant: American Edwards Laboratories
Product code: Code DYG
Advisory panel: Cardiovascular
Date received: 1981-01-19
Decision date: 1981-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.