UNICATH SP BI-PLANE (MODEL M269 & M289)— 510(k) K973744

Substantially Equivalent

Xre Corp.

FDA 510(k) clearance K973744 for UNICATH SP BI-PLANE (MODEL M269 & M289), Substantially Equivalent on 1997-12-29. Applicant: Xre Corp..

Clearance details

Applicant: Xre Corp.
Product code: Code JAA
Advisory panel: Radiology
Date received: 1997-10-01
Decision date: 1997-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Littleton, MA, US

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Adverse events under product code JAA

product code JAA

Other: 1
Total: 1

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.