FDA 510(k)

Spectranetics Turbo-Elite Laser Atherectomy Catheters

Número K: K170059 · 2017-04-07

Data da decisão2017-04-07

Código do produtoMCW

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Spectranetics Turbo-Elite Laser Atherectomy Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Spectranetics, Inc.. It received FDA 510(k) clearance on 2017-04-07 under 510(k) number K170059. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Spectranetics Turbo-Elite Laser Atherectomy Catheters?

Spectranetics Turbo-Elite Laser Atherectomy Catheters is a medical device that received FDA 510(k) clearance on 2017-04-07. The listed applicant is Spectranetics, Inc.. The 510(k) number is K170059.

When did Spectranetics Turbo-Elite Laser Atherectomy Catheters receive FDA 510(k) clearance?

Spectranetics Turbo-Elite Laser Atherectomy Catheters received FDA 510(k) clearance on 2017-04-07, under 510(k) number K170059.

Who is the listed applicant for Spectranetics Turbo-Elite Laser Atherectomy Catheters?

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

What is the FDA product code for Spectranetics Turbo-Elite Laser Atherectomy Catheters?

The FDA product code for Spectranetics Turbo-Elite Laser Atherectomy Catheters is MCW.

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Dispositivos Relacionados (Código: 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.

Fonte oficial

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