FDA 510(k)

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K-번호: K210146 · 2022-04-13

신청자Orthopedic Designs North America, Inc.

결정일2022-04-13

제품 코드HWC

자문 위원회의료장비 규제 텍스트 번역 [회사명]의 [제품명]은 미국 식품의약국(FDA)에 등록된 의료장비로, 510(k) 신청을 통해 승인받았습니다. PMA(Premarket Approval) 신청이 진행 중이며, 연구 등록 번호(NCT)는 [NCT 번호]입니다. 논문 등록 번호(PMID)는 [PMID 번호]입니다. 더 자세한 정보는 다음 URL을 참조하세요: [URL] 정책: medical-regulatory-v1

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기기 요약

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.

자주 묻는 질문

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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