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 PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES

K-Number: K180784 · 2018-07-18

ApplicantAsahi Intecc Co., Ltd.
Decision Date2018-07-18
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES is a medical device manufactured by Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2018-07-18 under approval number K180784. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES?

ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES is a medical device that received FDA 510(k) clearance on 2018-07-18. It is manufactured by Asahi Intecc Co., Ltd.. The 510(k) number is K180784.

When was ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES approved by the FDA?

ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES received FDA 510(k) clearance on 2018-07-18, under approval number K180784.

What company makes ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES?

ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES is manufactured by Asahi Intecc Co., Ltd..

What is the FDA product code for ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES?

The FDA product code for ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES is DQX.

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 K160659ASAHI CHIKAI Neurovascular Guide Wire (Round Curve)

View all 45 devices →

Related Devices (Code: DQX)

K160785Worker GuidewireArgon Medical Devices, Inc. K161702Endura guidewireVascular Solutions, Inc. K160594MRWire Guide WireNano4imaging GmbH K160643ENROUTE 0.014 GuidewireLake Region Medical K153685Sunmed Haemostatic ValvesSunny Medical Device (Shenzhen) Co., Ltd. K161584ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16Asahi Intecc Co., Ltd.

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.

↑