FDA 510(k)

MINAMO blue; MINAMO viola

K-Number: K240387 · 2024-06-21

Decision Date2024-06-21

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MINAMO blue; MINAMO viola is a medical device manufactured by Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2024-06-21 under approval number K240387. 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 MINAMO blue; MINAMO viola?

MINAMO blue; MINAMO viola is a medical device that received FDA 510(k) clearance on 2024-06-21. It is manufactured by Asahi Intecc Co., Ltd.. The 510(k) number is K240387.

When was MINAMO blue; MINAMO viola approved by the FDA?

MINAMO blue; MINAMO viola received FDA 510(k) clearance on 2024-06-21, under approval number K240387.

What company makes MINAMO blue; MINAMO viola?

MINAMO blue; MINAMO viola is manufactured by Asahi Intecc Co., Ltd..

What is the FDA product code for MINAMO blue; MINAMO viola?

The FDA product code for MINAMO blue; MINAMO viola 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.