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 a medical device manufactured by Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2026-05-11 under approval 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. It is manufactured by Asahi Intecc Co., Ltd.. The 510(k) number is K254178.
When was SAYA 86 Radial Access Guide Catheter approved by the FDA?
SAYA 86 Radial Access Guide Catheter received FDA 510(k) clearance on 2026-05-11, under approval number K254178.
What company makes SAYA 86 Radial Access Guide Catheter?
SAYA 86 Radial Access Guide Catheter is manufactured by Asahi Intecc Co., Ltd..
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.
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.