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FDA 510(k)

DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System

K-Number: K220109 · 2022-03-01

ApplicantCardiovascular Systems, Inc.
Decision Date2022-03-01
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System is a medical device manufactured by Cardiovascular Systems, Inc.. It received FDA 510(k) clearance on 2022-03-01 under approval number K220109. 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 DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System?

DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System is a medical device that received FDA 510(k) clearance on 2022-03-01. It is manufactured by Cardiovascular Systems, Inc.. The 510(k) number is K220109.

When was DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System approved by the FDA?

DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System received FDA 510(k) clearance on 2022-03-01, under approval number K220109.

What company makes DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System?

DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System is manufactured by Cardiovascular Systems, Inc..

What is the FDA product code for DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System?

The FDA product code for DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System is MCW.

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 41251011 Effectivity of the Dehydrated Human Amnion/Chorion Membrane Allograft for Diabetic Foot Ulcers in Japan: A Case Series. International wound journal (2025) PMID: 40077817 Research Progress on Neural Cell Culture Systems. Current neuropharmacology (2025)

Other Devices by Cardiovascular Systems, Inc.

K170792Diamondback 360 Peripheral Orbital Atherectomy System K183000ViperCath XC Peripheral Exchange Catheter K182397Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series K180416ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System K190634Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System K203008DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System

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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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