Revolution Peripheral Atherectomy System— 510(k) K212351

Substantially Equivalent

Rex Medical, L.P.

FDA 510(k) clearance K212351 for Revolution Peripheral Atherectomy System, Substantially Equivalent on 2021-12-15. Applicant: Rex Medical, L.P..

Clearance details

Applicant: Rex Medical, L.P.
Product code: Code MCW
Advisory panel: Cardiovascular
Date received: 2021-07-29
Decision date: 2021-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Conshohocken, PA, US

Download summary PDF View on FDA.gov ↗

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.