510(k) K200374— Columbus Guidewire

Substantially Equivalent

Rapid-Medical , Ltd.

Clearance details

Applicant: Rapid-Medical , Ltd.
Product code: Code MOF
Advisory panel: Cardiovascular
Date received: 2020-02-14
Decision date: 2020-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokneam, IL

Adverse events under product code MOF

product code MOF

Death: 6
Injury: 137
Total: 143

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.