FDA 510(k)

BNLE 수용성 재질 접시형 주위경도선

K-번호: K232662 · 2024-05-14

결정일2024-05-14

제품 코드DQX

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

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기기 요약

BNLE Hydrophilic Jacketed Peripheral Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Biomerics Nle. It received FDA 510(k) clearance on 2024-05-14 under 510(k) number K232662. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the BNLE Hydrophilic Jacketed Peripheral Guidewire?

BNLE Hydrophilic Jacketed Peripheral Guidewire is a medical device that received FDA 510(k) clearance on 2024-05-14. The listed applicant is Biomerics Nle. The 510(k) number is K232662.

When did BNLE Hydrophilic Jacketed Peripheral Guidewire receive FDA 510(k) clearance?

BNLE Hydrophilic Jacketed Peripheral Guidewire received FDA 510(k) clearance on 2024-05-14, under 510(k) number K232662.

Who is the listed applicant for BNLE Hydrophilic Jacketed Peripheral Guidewire?

The FDA 510(k) record lists Biomerics Nle as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BNLE Hydrophilic Jacketed Peripheral Guidewire?

The FDA product code for BNLE Hydrophilic Jacketed Peripheral Guidewire is DQX.

Biomerics Nle를 신청인으로 등재한 기타 기록

K221390BNLE 접근 가이드웨이

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