RAPID THERMAL EXCHANGE SYSTEM— 510(k) K023934

Substantially Equivalent

Avacore Technologies, Inc.

FDA 510(k) clearance K023934 for RAPID THERMAL EXCHANGE SYSTEM, Substantially Equivalent on 2003-01-23. Applicant: Avacore Technologies, Inc..

Clearance details

Applicant: Avacore Technologies, Inc.
Product code: Code DWJ
Advisory panel: Cardiovascular
Date received: 2002-11-26
Decision date: 2003-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, 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.