FDA 510(k)

マイクロ플렉스コ일システム (MCS), 히드로콜엠보리크시스템 (HES)

K-번호: K153594 · 2016-01-22

결정일2016-01-22

제품 코드HCG

자문 위원회NE (이 문서는 원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.)

결정대체적으로 동일

기기 요약

MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) is the device name listed in this FDA 510(k) record. The listed applicant is MicroVention, Inc.. It received FDA 510(k) clearance on 2016-01-22 under 510(k) number K153594. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)?

MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) is a medical device that received FDA 510(k) clearance on 2016-01-22. The listed applicant is MicroVention, Inc.. The 510(k) number is K153594.

When did MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) receive FDA 510(k) clearance?

MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) received FDA 510(k) clearance on 2016-01-22, under 510(k) number K153594.

Who is the listed applicant for MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)?

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

What is the FDA product code for MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)?

The FDA product code for MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) is HCG.

MicroVention, Inc.를 신청인으로 등재한 기타 기록

K232542위드지 엑스엘 전달 캐터터 K230775소피아 EX 대뇌 지지 캐터터 K222694EmPro EPS (EP4514C-190, EP6514C-190); Nanoparasol EPS (PNP4514C-190, PNP6514C-190)K222115아이자크 신경혈관 나비게이션 캐터터 K223050AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)K214024소피아 88 캐터터

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