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)

Vassallo GT 018 Hybrid

K-Number: K223432 · 2023-03-09

ApplicantFilmecc Co., Ltd.
Decision Date2023-03-09
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Vassallo GT 018 Hybrid is a medical device manufactured by Filmecc Co., Ltd.. It received FDA 510(k) clearance on 2023-03-09 under approval number K223432. 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 Vassallo GT 018 Hybrid?

Vassallo GT 018 Hybrid is a medical device that received FDA 510(k) clearance on 2023-03-09. It is manufactured by Filmecc Co., Ltd.. The 510(k) number is K223432.

When was Vassallo GT 018 Hybrid approved by the FDA?

Vassallo GT 018 Hybrid received FDA 510(k) clearance on 2023-03-09, under approval number K223432.

What company makes Vassallo GT 018 Hybrid?

Vassallo GT 018 Hybrid is manufactured by Filmecc Co., Ltd..

What is the FDA product code for Vassallo GT 018 Hybrid?

The FDA product code for Vassallo GT 018 Hybrid is DQX.

Other Devices by Filmecc Co., Ltd.

K203529VASSALLO GT Hybrid K203533VASSALLO GT K222631VASSALLO GT EXT K213949VASSALLO GT 018 Floppy

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.

↑