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 K181828
Device Name Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile
Applicant
Scientia Vascular, LLC
3487 W. 2100 S., Suite 100
West Valley City,  UT  84119
Applicant Contact David Sabodski
Correspondent
Scientia Vascular, LLC
3487 W. 2100 S., Suite 100
West Valley City,  UT  84119
Correspondent Contact David Sabodski
Regulation Number870.1330
Classification Product Code
MOF  
Subsequent Product Code
DQX  
Date Received07/09/2018
Decision Date 08/07/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-