RADIUS NEXT GENERATION GUIDEWIRE— 510(k) K011759

Substantially Equivalent

Radius Medical Technologies, Inc.

FDA 510(k) clearance K011759 for RADIUS NEXT GENERATION GUIDEWIRE, Substantially Equivalent on 2001-08-23. Applicant: Radius Medical Technologies, Inc..

Clearance details

Applicant: Radius Medical Technologies, Inc.
Product code: Code OCY
Advisory panel: Gastroenterology, Urology
Date received: 2001-06-06
Decision date: 2001-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maynard, MA, US

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Adverse events under product code OCY

product code OCY

Injury: 186
Malfunction: 578
Total: 764

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.