THERMO-STAT SYSTEM— 510(k) K970367

Substantially Equivalent

Aquarius Medical Corp.

FDA 510(k) clearance K970367 for THERMO-STAT SYSTEM, Substantially Equivalent on 1997-12-17. Applicant: Aquarius Medical Corp..

Clearance details

Applicant: Aquarius Medical Corp.
Product code: Code DWJ
Advisory panel: Cardiovascular
Date received: 1997-01-31
Decision date: 1997-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scottsdale, AZ, US

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Adverse events under product code DWJ

product code DWJ

Death: 7
Injury: 679
Malfunction: 17,477
Total: 18,163

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.