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FDA 510(k)

FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)

K-Number: K240460 · 2024-06-13

ApplicantFMD Co., Ltd.
Decision Date2024-06-13
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259) 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 2024-06-13 under 510(k) number K240460. 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 Wire F-18 Flex 400 (CSU415400259)?

FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259) is a medical device that received FDA 510(k) clearance on 2024-06-13. The listed applicant is FMD Co., Ltd.. The 510(k) number is K240460.

When did FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259) receive FDA 510(k) clearance?

FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259) received FDA 510(k) clearance on 2024-06-13, under 510(k) number K240460.

Who is the listed applicant for FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)?

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 Wire F-18 Flex 400 (CSU415400259)?

The FDA product code for FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259) 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.

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

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.

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 40K212268FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT

Related Devices (Code: DQX)

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.

K253667Accoat Guide WireSp Medical A/SK261640Merit 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 MedicalK253262EmeryGlide™ (EG18008901)Nano4imaging GmbH

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.

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