• 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 wire, guide, catheter
510(k) Number K192783
Device Name Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile
Applicant
Scientia Vascular LLC
3487 West 2100 South Suite 100
west valley city,  UT  84119
Applicant Contact amy mcmanus
Correspondent
Scientia Vascular LLC
3487 West 2100 South Suite 100
west valley city,  UT  84119
Correspondent Contact amy mcmanus
Regulation Number870.1330
Classification Product Code
DQX  
Subsequent Product Code
MOF  
Date Received09/30/2019
Decision Date 10/30/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-