Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Revolution Peripheral Atherectomy System

K-Number: K212351 · 2021-12-15

ApplicantRex Medical, L.P.
Decision Date2021-12-15
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Revolution Peripheral Atherectomy System is the device name listed in this FDA 510(k) record. The listed applicant is Rex Medical, L.P.. It received FDA 510(k) clearance on 2021-12-15 under 510(k) number K212351. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Revolution Peripheral Atherectomy System?

Revolution Peripheral Atherectomy System is a medical device that received FDA 510(k) clearance on 2021-12-15. The listed applicant is Rex Medical, L.P.. The 510(k) number is K212351.

When did Revolution Peripheral Atherectomy System receive FDA 510(k) clearance?

Revolution Peripheral Atherectomy System received FDA 510(k) clearance on 2021-12-15, under 510(k) number K212351.

Who is the listed applicant for Revolution Peripheral Atherectomy System?

The FDA 510(k) record lists Rex Medical, L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Revolution Peripheral Atherectomy System?

The FDA product code for Revolution Peripheral Atherectomy System is MCW.

Other records listing Rex Medical, L.P. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K191419Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy GuidewirePMA P150022Device, hemostasis, vascularK173389Rex Medical Aspiration Pump

Related Devices (Code: MCW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260244Auryon Atherectomy SystemEximo MedicalK250723FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)Cardio Flow Inc.,K250385Turbo-Elite Laser Atherectomy CatheterSpectraneticsK242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc.K242947FreedomFlow™ Orbital Circumferential Atherectomy SystemCardio Flow Inc.,K241553Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingEximo Medical, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑