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FDA 510(k)

Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14)

K-Number: K260168 · 2026-10-16

ApplicantSkycade Med Corporation
Decision Date2026-10-16
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) is the device name listed in this FDA 510(k) record. The listed applicant is Skycade Med Corporation. It received FDA 510(k) clearance on 2026-10-16 under 510(k) number K260168. 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 Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14)?

Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) is a medical device that received FDA 510(k) clearance on 2026-10-16. The listed applicant is Skycade Med Corporation. The 510(k) number is K260168.

When did Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) receive FDA 510(k) clearance?

Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) received FDA 510(k) clearance on 2026-10-16, under 510(k) number K260168.

Who is the listed applicant for Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14)?

The FDA 510(k) record lists Skycade Med Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14)?

The FDA product code for Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

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.

K253146Hyperdrive 35 GuidewireRapid-Medical , Ltd.K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd.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.

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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