Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Guide, Wire, Catheter, Neurovasculature
510(k) Number K240871
Device Name Synxess Neurovascular Guidewire
Applicant
Enlight Medical Technologies (Shenzhen) Co., Ltd.
5-6/F, Building A, Xinghui Technology Industrial Park
52 Huaning Rd, Xinshi Community, Dalang St, Longhua District
Shenzhen,  CN 518109
Applicant Contact Gui Kason
Correspondent
Enlight Medical Technologies (Shenzhen) Co., Ltd.
5-6/F, Building A, Xinghui Technology Industrial Park
52 Huaning Rd, Xinshi Community, Dalang St, Longhua District
Shenzhen,  CN 518109
Correspondent Contact Gui Kason
Regulation Number870.1330
Classification Product Code
MOF  
Date Received03/29/2024
Decision Date 11/18/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-