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FDA 510(k)

ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension

K-Number: K163426 · 2017-04-03

ApplicantAsahi Intecc Co., Ltd.
Decision Date2017-04-03
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension 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 2017-04-03 under 510(k) number K163426. 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 ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension?

ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension is a medical device that received FDA 510(k) clearance on 2017-04-03. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K163426.

When did ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension receive FDA 510(k) clearance?

ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension received FDA 510(k) clearance on 2017-04-03, under 510(k) number K163426.

Who is the listed applicant for ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension?

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 ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension?

The FDA product code for ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension 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.

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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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