Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ASAHI CHIKAI Neurovascular Guide Wire (Round Curve)

K-Number: K160659 · 2016-04-07

ApplicantAsahi Intecc Co., Ltd.
Decision Date2016-04-07
Product CodeMOF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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

When was ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) approved by the FDA?

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

What company makes ASAHI CHIKAI Neurovascular Guide Wire (Round Curve)?

ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) is manufactured by Asahi Intecc Co., Ltd..

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.

Related Clinical Trials

NCT07600502 Establish Whether Hyperangulated Videolaryngoscopy (HAVL) Can be Used to Facilitate Tracheal Intubation Effectively and Safely in Unselected Adult Patients; Describe the Population in Whom HAVL Fails to Facilitate Tracheal Intubation Successfully, Identifying Any Contributory Characteristics. NOT_YET_RECRUITING NCT07561372 Adaptive Recruitment Curve Analysis Using Bayesian Modeling NOT_YET_RECRUITING

Other Devices by Asahi Intecc Co., Ltd.

K161912ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip K161584ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16 K161126ASAHI Corsair Pro K153106ASAHI Fielder XT-A, ASAHI Fielder XT-R K161362ASAHI Corsair Armet K152249ASAHI Corsair Armet

View all 45 devices →

Related Devices (Code: MOF)

K163154Traxcess 7 Mini XSoft GuidewireMicroVention, Inc. K161912ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tipAsahi Intecc Co., Ltd. K161803Traxcess .007 Mini GuidewireMicroVention, Inc. K171613ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tipAsahi Intecc Co., Ltd. K182337HYBRID GuidewireBalt USA, LLC K181828Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard ProfileScientia Vascular, 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.

↑