Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire— 510(k) K191419

Substantially Equivalent

Rex Medical, L.P.

FDA 510(k) clearance K191419 for Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire, Substantially Equivalent on 2019-09-12. Applicant: Rex Medical, L.P..

Clearance details

Applicant: Rex Medical, L.P.
Product code: Code MCW
Advisory panel: Cardiovascular
Date received: 2019-05-28
Decision date: 2019-09-12
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.