GAMGRO ENGSTROM Y FILTER WITH EDITH FLEX (1500 F), EDIT 500, 1000, 2600 AND Y FILTER PACKAGED ALONE— 510(k) K945543

Name: FDA 510(k) clearance K945543
Creator: U.S. Food and Drug Administration
Published: 1994-11-29

Substantially Equivalent

Intersect Medical Products, Inc.

FDA 510(k) clearance K945543 for GAMGRO ENGSTROM Y FILTER WITH EDITH FLEX (1500 F), EDIT 500, 1000, 2600 AND Y FILTER PACKAGED ALONE, Substantially Equivalent on 1994-11-29. Applicant: Intersect Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: Intersect Medical Products, Inc.
Product code: Code CAH
Device class: Class 2
Regulation: 21 CFR 868.5260
Advisory panel: Anesthesiology
Date received: 1994-11-14
Decision date: 1994-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CAH

product code CAH

Death: 7
Total: 7

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.