510(k) K896020— EXTRACORPOREAL HEAT EXCHANGER HE SERIES

Substantially Equivalent

Gish Biomedical, Inc.

Clearance details

Applicant: Gish Biomedical, Inc.
Product code: Code DTR
Advisory panel: Cardiovascular
Date received: 1989-10-16
Decision date: 1990-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Adverse events under product code DTR

product code DTR

Other: 1
Total: 1

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.