FDA 510(k)

ASAHI Neurovascular Guide Wire CHIKAI X 014 soft

K-Number: K191714 · 2019-07-26

Decision Date2019-07-26

Product CodeMOF

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ASAHI Neurovascular Guide Wire CHIKAI X 014 soft is the device name listed in this FDA 510(k) record. The listed applicant is Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2019-07-26 under 510(k) number K191714. The device is classified under product code MOF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASAHI Neurovascular Guide Wire CHIKAI X 014 soft?

ASAHI Neurovascular Guide Wire CHIKAI X 014 soft is a medical device that received FDA 510(k) clearance on 2019-07-26. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K191714.

When did ASAHI Neurovascular Guide Wire CHIKAI X 014 soft receive FDA 510(k) clearance?

ASAHI Neurovascular Guide Wire CHIKAI X 014 soft received FDA 510(k) clearance on 2019-07-26, under 510(k) number K191714.

Who is the listed applicant for ASAHI Neurovascular Guide Wire CHIKAI X 014 soft?

The FDA 510(k) record lists Asahi Intecc Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASAHI Neurovascular Guide Wire CHIKAI X 014 soft?

The FDA product code for ASAHI Neurovascular Guide Wire CHIKAI X 014 soft is MOF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07511478Fibula Plating vs Intramedullary K-Wire in Bimalleolar Ankle FracturesCOMPLETED

Other records listing Asahi Intecc Co., Ltd. as applicant

K254178SAYA 86 Radial Access Guide Catheter K252011CHIKAI Nexus petit K251560FUBUKI XF-R Neurovascular Long Sheath K251240Branchor X Balloon Guide Catheter K243383CHIKAI Nexus 014 K243733SION blue PLUS

View all 45 devices →

Related Devices (Code: MOF)

K262424Willow 12 GuidewireArbor Endovascular, LLC K260223Aristotle Mini GuidewireScientia Vascular, Inc.K254006Drivewire 35 GuidewireRapid Medical Ltd.K253579Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 GuidewireScientia Vascular, Inc.K252317Zenith Micro GuidewireSuzhou Zenith Vascular SciTech Limited K260537Willow 24 GuidewireArbor Endovascular, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.