FDA 510(k)

Cannulated Compression Device System

Número K: K210146 · 2022-04-13

RequerenteOrthopedic Designs North America, Inc.

Data da decisão2022-04-13

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Cannulated Compression Device System is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Designs North America, Inc.. It received FDA 510(k) clearance on 2022-04-13 under 510(k) number K210146. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Cannulated Compression Device System?

Cannulated Compression Device System is a medical device that received FDA 510(k) clearance on 2022-04-13. The listed applicant is Orthopedic Designs North America, Inc.. The 510(k) number is K210146.

When did Cannulated Compression Device System receive FDA 510(k) clearance?

Cannulated Compression Device System received FDA 510(k) clearance on 2022-04-13, under 510(k) number K210146.

Who is the listed applicant for Cannulated Compression Device System?

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

What is the FDA product code for Cannulated Compression Device System?

The FDA product code for Cannulated Compression Device System is HWC. This falls under the Cardiovascular category.

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Fonte oficial

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