FDA 510(k)

ASAHI CHIKAI Neurovascular Guide Wire (Round Curve)

K-Number: K160659 · 2016-04-07

Decision Date2016-04-07

Product CodeMOF

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) 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 2016-04-07 under 510(k) number K160659. 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 CHIKAI Neurovascular Guide Wire (Round Curve)?

ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) is a medical device that received FDA 510(k) clearance on 2016-04-07. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K160659.

When did ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) receive FDA 510(k) clearance?

ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) received FDA 510(k) clearance on 2016-04-07, under 510(k) number K160659.

Who is the listed applicant for ASAHI CHIKAI Neurovascular Guide Wire (Round Curve)?

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 CHIKAI Neurovascular Guide Wire (Round Curve)?

The FDA product code for ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) is MOF.

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

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.

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.