MODIFIED VERSION IMPLANTABLE VASCULAR ACCESS SYSTE— 510(k) K912111

Substantially Equivalent

Gerard Medical Enterprises, Inc.

FDA 510(k) clearance K912111 for MODIFIED VERSION IMPLANTABLE VASCULAR ACCESS SYSTE, Substantially Equivalent on 1991-10-08. Applicant: Gerard Medical Enterprises, Inc..

Clearance details

Applicant: Gerard Medical Enterprises, Inc.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 1991-05-13
Decision date: 1991-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brimfield, MA, US

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Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.