FDA 510(k)

CROSSLEAD Peripheral Guide Wire

K-Number: K213315 · 2022-07-01

Decision Date2022-07-01

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CROSSLEAD Peripheral Guide Wire is the device name listed in this FDA 510(k) record. The listed applicant is Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2022-07-01 under 510(k) number K213315. 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 CROSSLEAD Peripheral Guide Wire?

CROSSLEAD Peripheral Guide Wire is a medical device that received FDA 510(k) clearance on 2022-07-01. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K213315.

When did CROSSLEAD Peripheral Guide Wire receive FDA 510(k) clearance?

CROSSLEAD Peripheral Guide Wire received FDA 510(k) clearance on 2022-07-01, under 510(k) number K213315.

Who is the listed applicant for CROSSLEAD Peripheral Guide Wire?

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

What is the FDA product code for CROSSLEAD Peripheral Guide Wire?

The FDA product code for CROSSLEAD Peripheral Guide Wire 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 Asahi Intecc Co., Ltd. as applicant

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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

View on FDA Database →

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