FDA 510(k)

ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire

Número K: K220654 · 2022-04-06

Data da decisão2022-04-06

Código do produtoNTE

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corporation. It received FDA 510(k) clearance on 2022-04-06 under 510(k) number K220654. The device is classified under product code NTE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire?

ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire is a medical device that received FDA 510(k) clearance on 2022-04-06. The listed applicant is Cordis Corporation. The 510(k) number is K220654.

When did ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire receive FDA 510(k) clearance?

ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire received FDA 510(k) clearance on 2022-04-06, under 510(k) number K220654.

Who is the listed applicant for ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire?

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

What is the FDA product code for ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire?

The FDA product code for ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire is NTE.

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Fonte oficial

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