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FDA 510(k)

Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire

K-Number: K191419 · 2019-09-12

ApplicantRex Medical, L.P.
Decision Date2019-09-12
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire is a medical device manufactured by Rex Medical, L.P.. It received FDA 510(k) clearance on 2019-09-12 under approval number K191419. 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 Guidewire?

Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire is a medical device that received FDA 510(k) clearance on 2019-09-12. It is manufactured by Rex Medical, L.P.. The 510(k) number is K191419.

When was Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire approved by the FDA?

Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire received FDA 510(k) clearance on 2019-09-12, under approval number K191419.

What company makes Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire?

Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire is manufactured by Rex Medical, L.P..

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

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

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Related PubMed Literature

PMID: 40077817 Research Progress on Neural Cell Culture Systems. Current neuropharmacology (2025)

Other Devices by Rex Medical, L.P.

K173389Rex Medical Aspiration Pump K212351Revolution Peripheral Atherectomy System PMA P150022Device, hemostasis, vascular

Related Devices (Code: MCW)

K163264Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox SledAvinger, Inc. K162326Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SledAvinger, Inc. K161361HawkOne Directional Atherectomy SystemMedtronic Vascular, Inc. K160827Pantheris CatheterAvinger, Inc. K153460Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)Avinger, Inc. K172687Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy CathetersSpectranetics, Inc.

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.

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