SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM)— 510(k) K910204

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K910204 for SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM), Substantially Equivalent on 1991-04-24. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code DQO
Advisory panel: Cardiovascular
Date received: 1991-01-16
Decision date: 1991-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

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Adverse events under product code DQO

product code DQO

Death: 35
Injury: 993
Malfunction: 1,772
Other: 5
Total: 2,805

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.