FDA 510(k)

Single-use Sterile High-pressure Angiographic Syringes and Accessories

Número K: K241109 · 2024-08-22

RequerenteShenzhen Boon Medical Supply Co., Ltd.

Data da decisão2024-08-22

Código do produtoDXT

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Single-use Sterile High-pressure Angiographic Syringes and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Boon Medical Supply Co., Ltd.. It received FDA 510(k) clearance on 2024-08-22 under 510(k) number K241109. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Single-use Sterile High-pressure Angiographic Syringes and Accessories?

Single-use Sterile High-pressure Angiographic Syringes and Accessories is a medical device that received FDA 510(k) clearance on 2024-08-22. The listed applicant is Shenzhen Boon Medical Supply Co., Ltd.. The 510(k) number is K241109.

When did Single-use Sterile High-pressure Angiographic Syringes and Accessories receive FDA 510(k) clearance?

Single-use Sterile High-pressure Angiographic Syringes and Accessories received FDA 510(k) clearance on 2024-08-22, under 510(k) number K241109.

Who is the listed applicant for Single-use Sterile High-pressure Angiographic Syringes and Accessories?

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

What is the FDA product code for Single-use Sterile High-pressure Angiographic Syringes and Accessories?

The FDA product code for Single-use Sterile High-pressure Angiographic Syringes and Accessories is DXT.

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Outros registros que listam Shenzhen Boon Medical Supply Co., Ltd. como candidato(a)

K211564Sterile High-pressure Angiographic Syringes for Single-use K192657Sterile High-pressure Angiographic Syringes for Single-use

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Fonte oficial

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