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)

TalWire

K-Number: K223791 · 2023-07-14

ApplicantEmbrace Medical , Ltd.
Decision Date2023-07-14
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TalWire is a medical device manufactured by Embrace Medical , Ltd.. It received FDA 510(k) clearance on 2023-07-14 under approval number K223791. 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 TalWire?

TalWire is a medical device that received FDA 510(k) clearance on 2023-07-14. It is manufactured by Embrace Medical , Ltd.. The 510(k) number is K223791.

When was TalWire approved by the FDA?

TalWire received FDA 510(k) clearance on 2023-07-14, under approval number K223791.

What company makes TalWire?

TalWire is manufactured by Embrace Medical , Ltd..

What is the FDA product code for TalWire?

The FDA product code for TalWire is DQX.

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.

↑