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FDA 510(k)

Synxess Neurovascular Guidewire

K-Number: K240871 · 2024-11-18

ApplicantEnlight Medical Technologies (Shenzhen) Co., Ltd.
Decision Date2024-11-18
Product CodeMOF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Synxess Neurovascular Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Enlight Medical Technologies (Shenzhen) Co., Ltd.. It received FDA 510(k) clearance on 2024-11-18 under 510(k) number K240871. The device is classified under product code MOF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Synxess Neurovascular Guidewire?

Synxess Neurovascular Guidewire is a medical device that received FDA 510(k) clearance on 2024-11-18. The listed applicant is Enlight Medical Technologies (Shenzhen) Co., Ltd.. The 510(k) number is K240871.

When did Synxess Neurovascular Guidewire receive FDA 510(k) clearance?

Synxess Neurovascular Guidewire received FDA 510(k) clearance on 2024-11-18, under 510(k) number K240871.

Who is the listed applicant for Synxess Neurovascular Guidewire?

The FDA 510(k) record lists Enlight Medical Technologies (Shenzhen) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Synxess Neurovascular Guidewire?

The FDA product code for Synxess Neurovascular Guidewire is MOF.

Related Devices (Code: MOF)

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.

K262424Willow 12 GuidewireArbor Endovascular, LLCK260223Aristotle Mini GuidewireScientia Vascular, Inc.K254006Drivewire 35 GuidewireRapid Medical Ltd.K253579Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 GuidewireScientia Vascular, Inc.K252317Zenith Micro GuidewireSuzhou Zenith Vascular SciTech LimitedK260537Willow 24 GuidewireArbor Endovascular, LLC

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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