FDA 510(k)

Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system

Numéro K : K210586 · 2021-09-14

Date de décision2021-09-14

Code produitMCW

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system is the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascular Systems, Inc.. It received FDA 510(k) clearance on 2021-09-14 under 510(k) number K210586. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system?

Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system is a medical device that received FDA 510(k) clearance on 2021-09-14. The listed applicant is Cardiovascular Systems, Inc.. The 510(k) number is K210586.

When did Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system receive FDA 510(k) clearance?

Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system received FDA 510(k) clearance on 2021-09-14, under 510(k) number K210586.

Who is the listed applicant for Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system?

The FDA 510(k) record lists Cardiovascular Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system?

The FDA product code for Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system is MCW.

Essais cliniques associés

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Autres dossiers indiquant Cardiovascular Systems, Inc. en tant que demandeur

K220109DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System K212725ViperCross Support Catheters K211240ViperCross Support Catheters K211251ViperCath XC Peripheral Exchange Catheter K210282WIRION Embolic Protection 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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Dispositifs connexes (Code : MCW)

K260244Auryon Atherectomy SystemEximo Medical K250723FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)Cardio Flow Inc.,K250385Turbo-Elite Laser Atherectomy CatheterSpectranetics K242757Rotarex 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.

Source officielle

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