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FDA 510(k)

ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16

K-Number: K161584 · 2016-10-06

ApplicantAsahi Intecc Co., Ltd.
Decision Date2016-10-06
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16 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 2016-10-06 under 510(k) number K161584. 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® Peripheral Vascular Guide Wire ASAHI Meister®16?

ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16 is a medical device that received FDA 510(k) clearance on 2016-10-06. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K161584.

When did ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16 receive FDA 510(k) clearance?

ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16 received FDA 510(k) clearance on 2016-10-06, under 510(k) number K161584.

Who is the listed applicant for ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16?

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® Peripheral Vascular Guide Wire ASAHI Meister®16?

The FDA product code for ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16 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 SurvivalRECRUITINGNCT07779317Single Lumen Midline Catheter vs Ultrasound Guided Peripheral IV as Performed by Bedside Emergency Department Registered NursesRECRUITING

Other records listing Asahi Intecc Co., Ltd. as applicant

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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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