FDA.reportPublic FDA data

510(k) K240871

Device
Synxess Neurovascular Guidewire
Applicant
Enlight Medical Technologies (Shenzhen) Co., Ltd.
510(k) number
K240871
Product code
MOF
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-18
Date received
2024-03-29
Regulation
870.1330
Classification name
Guide, Wire, Catheter, Neurovasculature
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Gui Kason
Address
5-6/F, Bldg. A, Xinghui Technology Industrial Park 52 Huaning Rd., Xinshi Community, Dalang St., Longhua Distri Shenzhen CN 518109 518109

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MOF#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K233791Drivewire 24 GuidewireRapid-Medical , Ltd.2024-07-11
K231954Aristotle 18 Guidewire; Aristotle 24 GuidewireScientia Vascular, Inc.2023-08-01
K222690SmartGUIDE deflectable hydrophilic guidewireArtiria Medical SA2023-04-24
K220398Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 GuidewireScientia Vascular, LLC2023-03-10