MICROFUSE MEMBRANE INFUSION CATHETER— 510(k) K971619

Substantially Equivalent

E-Med Corp.

FDA 510(k) clearance K971619 for MICROFUSE MEMBRANE INFUSION CATHETER, Substantially Equivalent on 1998-02-27. Applicant: E-Med Corp..

Clearance details

Applicant: E-Med Corp.
Product code: Code KRA
Advisory panel: Cardiovascular
Date received: 1997-05-01
Decision date: 1998-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saint Paul, MN, US

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Adverse events under product code KRA

product code KRA

Death: 234
Injury: 1,029
Malfunction: 3,012
Other: 2
Total: 4,277

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.