FDA 510(k)

팔라딘 카롯idian 후확장 baloon 시스템 with integrated embolic protection (팔라딘 시스템)

K-번호: K181128 · 2018-09-06

결정일2018-09-06

제품 코드LIT

자문 위원회의료장비 규제 텍스트 번역 [회사명]의 [제품명]은 미국 식약국(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

결정대체적으로 동일

기기 요약

Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System) is the device name listed in this FDA 510(k) record. The listed applicant is Contego Medical, LLC. It received FDA 510(k) clearance on 2018-09-06 under 510(k) number K181128. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System)?

Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System) is a medical device that received FDA 510(k) clearance on 2018-09-06. The listed applicant is Contego Medical, LLC. The 510(k) number is K181128.

When did Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System) receive FDA 510(k) clearance?

Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System) received FDA 510(k) clearance on 2018-09-06, under 510(k) number K181128.

Who is the listed applicant for Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System)?

The FDA 510(k) record lists Contego Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System)?

The FDA product code for Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System) is LIT.

Contego Medical, LLC를 신청인으로 등재한 기타 기록

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