GAMBRO ENGSTROM Y-FILTER WITH EDITH FLEX (1500F)— 510(k) K914271

Substantially Equivalent

C.G.H. Medical, Inc.

FDA 510(k) clearance K914271 for GAMBRO ENGSTROM Y-FILTER WITH EDITH FLEX (1500F), Substantially Equivalent on 1992-04-13. Applicant: C.G.H. Medical, Inc..

Clearance details

Applicant: C.G.H. Medical, Inc.
Product code: Code CAN
Advisory panel: Anesthesiology
Date received: 1991-09-24
Decision date: 1992-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAN

product code CAN

Death: 4
Other: 1
Total: 5

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.