FDA 510(k)

ASAHI Fielder XT-A, ASAHI Fielder XT-R

K-Number: K153106 · 2016-06-21

Decision Date2016-06-21

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ASAHI Fielder XT-A, ASAHI Fielder XT-R 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 2016-06-21 under 510(k) number K153106. 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 Fielder XT-A, ASAHI Fielder XT-R?

ASAHI Fielder XT-A, ASAHI Fielder XT-R is a medical device that received FDA 510(k) clearance on 2016-06-21. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K153106.

When did ASAHI Fielder XT-A, ASAHI Fielder XT-R receive FDA 510(k) clearance?

ASAHI Fielder XT-A, ASAHI Fielder XT-R received FDA 510(k) clearance on 2016-06-21, under 510(k) number K153106.

Who is the listed applicant for ASAHI Fielder XT-A, ASAHI Fielder XT-R?

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 Fielder XT-A, ASAHI Fielder XT-R?

The FDA product code for ASAHI Fielder XT-A, ASAHI Fielder XT-R is DQX.

Other records listing Asahi Intecc 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.

K254178SAYA 86 Radial Access Guide Catheter K252011CHIKAI Nexus petit K251560FUBUKI XF-R Neurovascular Long Sheath K251240Branchor X Balloon Guide Catheter K243383CHIKAI Nexus 014 K243733SION blue PLUS

View all 45 devices →

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.