UNICATH EP.— 510(k) K913685

Substantially Equivalent

Xre Corp.

FDA 510(k) clearance K913685 for UNICATH EP., Substantially Equivalent on 1991-11-07. Applicant: Xre Corp..

Clearance details

Applicant: Xre Corp.
Product code: Code IZI
Advisory panel: Radiology
Date received: 1991-08-19
Decision date: 1991-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Littleton, MA, US

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Adverse events under product code IZI

product code IZI

Death: 9
Malfunction: 5,312
Total: 5,321

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.