510(k) K902845— GENTLE HEADER

Substantially Equivalent

Enhanced Perfusion Systems, Inc.

Clearance details

Applicant: Enhanced Perfusion Systems, Inc.
Product code: Code DWE
Advisory panel: Cardiovascular
Date received: 1990-06-28
Decision date: 1990-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grass Lake, MI, US

Adverse events under product code DWE

product code DWE

Death: 9
Malfunction: 754
Total: 763

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.