FDA 510(k)

Sterile High-pressure Angiographic Syringes for single-use

Numéro K : K201395 · 2020-10-28

DemandeurYouwo (Guangzhou) Medical Device Co., Ltd.

Date de décision2020-10-28

Code produitDXT

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

Sterile High-pressure Angiographic Syringes for single-use is the device name listed in this FDA 510(k) record. The listed applicant is Youwo (Guangzhou) Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2020-10-28 under 510(k) number K201395. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Sterile High-pressure Angiographic Syringes for single-use?

Sterile High-pressure Angiographic Syringes for single-use is a medical device that received FDA 510(k) clearance on 2020-10-28. The listed applicant is Youwo (Guangzhou) Medical Device Co., Ltd.. The 510(k) number is K201395.

When did Sterile High-pressure Angiographic Syringes for single-use receive FDA 510(k) clearance?

Sterile High-pressure Angiographic Syringes for single-use received FDA 510(k) clearance on 2020-10-28, under 510(k) number K201395.

Who is the listed applicant for Sterile High-pressure Angiographic Syringes for single-use?

The FDA 510(k) record lists Youwo (Guangzhou) Medical Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile High-pressure Angiographic Syringes for single-use?

The FDA product code for Sterile High-pressure Angiographic Syringes for single-use is DXT.

Essais cliniques associés

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Dispositifs connexes (Code : DXT)

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Source officielle

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