FDA 510(k)

FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT

K-Number: K212268 · 2022-05-27

Decision Date2022-05-27

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT is the device name listed in this FDA 510(k) record. The listed applicant is FMD Co., Ltd.. It received FDA 510(k) clearance on 2022-05-27 under 510(k) number K212268. 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 FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT?

FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT is a medical device that received FDA 510(k) clearance on 2022-05-27. The listed applicant is FMD Co., Ltd.. The 510(k) number is K212268.

When did FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT receive FDA 510(k) clearance?

FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT received FDA 510(k) clearance on 2022-05-27, under 510(k) number K212268.

Who is the listed applicant for FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT?

The FDA 510(k) record lists FMD Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT?

The FDA product code for FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT is DQX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT00453505Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous SystemCOMPLETED NCT06107361Evaluating the Role of the Guidewire in Peripheral Intravenous Access: A Randomized Controlled Trial of Ultrasound-Guided Catheter SurvivalRECRUITING

Other records listing FMD Co., Ltd. as applicant

K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40 K240460FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)

Related Devices (Code: DQX)

K253667Accoat Guide WireSp Medical A/S K261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland , Ltd.K254137InQwire Amplatz Guide WireMerit Medical Ireland, Ltd.K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40FMD Co., Ltd.K253746Enroute 0.014'' Transcarotid GuidewireLake Region Medical K253262EmeryGlide™ (EG18008901)Nano4imaging GmbH

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.