Rotarex Atherectomy System— 510(k) K211738

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K211738 for Rotarex Atherectomy System, Substantially Equivalent on 2021-09-14. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code MCW
Advisory panel: Cardiovascular
Date received: 2021-06-07
Decision date: 2021-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tempe, AZ, US

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Adverse events under product code MCW

product code MCW

Death: 38
Injury: 1,386
Malfunction: 2,676
Other: 2
Total: 4,102

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.