Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SION blue PLUS

K-Number: K243733 · 2025-04-02

ApplicantAsahi Intecc Co., Ltd.
Decision Date2025-04-02
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SION blue PLUS 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 2025-04-02 under 510(k) number K243733. 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 SION blue PLUS?

SION blue PLUS is a medical device that received FDA 510(k) clearance on 2025-04-02. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K243733.

When did SION blue PLUS receive FDA 510(k) clearance?

SION blue PLUS received FDA 510(k) clearance on 2025-04-02, under 510(k) number K243733.

Who is the listed applicant for SION blue PLUS?

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 SION blue PLUS?

The FDA product code for SION blue PLUS 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 CatheterK252011CHIKAI Nexus petitK251560FUBUKI XF-R Neurovascular Long SheathK251240Branchor X Balloon Guide CatheterK243383CHIKAI Nexus 014K241962Crossloop

View all 45 devices →

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.

↑