GENTLE HEADER— 510(k) K902845

Name: FDA 510(k) clearance K902845
Creator: U.S. Food and Drug Administration
Published: 1990-12-03

Substantially Equivalent

Enhanced Perfusion Systems, Inc.

FDA 510(k) clearance K902845 for GENTLE HEADER, Substantially Equivalent on 1990-12-03. Applicant: Enhanced Perfusion Systems, Inc.. Device class: 2.

Clearance details

Applicant: Enhanced Perfusion Systems, Inc.
Product code: Code DWE
Device class: Class 2
Regulation: 21 CFR 870.4390
Advisory panel: Cardiovascular
Date received: 1990-06-28
Decision date: 1990-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grass Lake, MI, US

Download summary PDF View on FDA.gov ↗

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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.