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)

EpiFaith CV

K-Number: K212615 · 2022-09-21

ApplicantFlat Medical Co., Ltd.
Decision Date2022-09-21
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EpiFaith CV is a medical device manufactured by Flat Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-09-21 under approval number K212615. 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 EpiFaith CV?

EpiFaith CV is a medical device that received FDA 510(k) clearance on 2022-09-21. It is manufactured by Flat Medical Co., Ltd.. The 510(k) number is K212615.

When was EpiFaith CV approved by the FDA?

EpiFaith CV received FDA 510(k) clearance on 2022-09-21, under approval number K212615.

What company makes EpiFaith CV?

EpiFaith CV is manufactured by Flat Medical Co., Ltd..

What is the FDA product code for EpiFaith CV?

The FDA product code for EpiFaith CV is DQX.

Other Devices by Flat Medical Co., Ltd.

K192421EpiFaith Syringe K182268EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit)

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.

↑