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FDA 510(k)

SAYA 86 Radial Access Guide Catheter

K-Number: K254178 · 2026-05-11

ApplicantAsahi Intecc Co., Ltd.
Decision Date2026-05-11
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SAYA 86 Radial Access Guide Catheter 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 2026-05-11 under 510(k) number K254178. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAYA 86 Radial Access Guide Catheter?

SAYA 86 Radial Access Guide Catheter is a medical device that received FDA 510(k) clearance on 2026-05-11. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K254178.

When did SAYA 86 Radial Access Guide Catheter receive FDA 510(k) clearance?

SAYA 86 Radial Access Guide Catheter received FDA 510(k) clearance on 2026-05-11, under 510(k) number K254178.

Who is the listed applicant for SAYA 86 Radial Access Guide Catheter?

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 SAYA 86 Radial Access Guide Catheter?

The FDA product code for SAYA 86 Radial Access Guide Catheter is QJP.

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 SurvivalRECRUITINGNCT06668766Single Lumen Midline Catheter vs Long Peripheral Intravenous Cather for Difficult Intravenous Access in the EDCOMPLETEDNCT07762560Routine Microaxial Heart Pump Support and Protocolized Pulmonary Artery Catheter Monitoring Versus Standard Care in Heart Attack-Related Cardiogenic ShockNOT_YET_RECRUITINGNCT07779317Single 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

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.

K252011CHIKAI Nexus petitK251560FUBUKI XF-R Neurovascular Long SheathK251240Branchor X Balloon Guide CatheterK243383CHIKAI Nexus 014K243733SION blue PLUSK241962Crossloop

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Related Devices (Code: QJP)

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.

K260199SLIM MicrocatheterBalt USA, LLCK253901Millipede88 Access CatheterPerfuze, Ltd.K261889Trevo Trak 21 MicrocatheterStryker NeurovascularK261808ISAAC Neurovascular Navigation CatheterMicrovention Inc. d/b/a Terumo NeuroK261549BOBBY Balloon Guide CatheterMicroVention, Inc., d/b/a Terumo NeuroK253359Zenith Distal Access Long SheathSuzhou Zenith Vascular SciTech Limited

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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