FDA 510(k)

V-Grip 切離制御装置（Hydrocoil 膨脹栓塞システムおよびMicroPlex 膨脹栓塞システム用）、AZUR 切離制御装置（AZUR 周辺コイルシステム用）

K番号: K162999 · 2017-03-29

決定日2017-03-29

製品コードHCG

諮問委員会Please provide the source text to translate.

決定大幅同等

医療機器の概要

V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System is the device name listed in this FDA 510(k) record. The listed applicant is MicroVention, Inc.. It received FDA 510(k) clearance on 2017-03-29 under 510(k) number K162999. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System?

V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System is a medical device that received FDA 510(k) clearance on 2017-03-29. The listed applicant is MicroVention, Inc.. The 510(k) number is K162999.

When did V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System receive FDA 510(k) clearance?

V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System received FDA 510(k) clearance on 2017-03-29, under 510(k) number K162999.

Who is the listed applicant for V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System?

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 V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System?

The FDA product code for V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System is HCG.

申請者としてMicroVention, Inc.を記載するその他の記録

K232542ウェジ・エックスL デリバリーカテター K230775SOFIA EX 脳室内支持カテーテル K222694EmPro EPS（EP4514C-190、EP6514C-190）；Nanoparasol EPS（PNP4514C-190、PNP6514C-190）K222115ISAAC神経血管ナビゲーションカテーテル K223050AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)K214024SOFIA 88 カテーテル

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