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 Catheter, Intravascular, Diagnostic
510(k) Number K192122
Device Name Trevo Trak 21 Microcatheter
Applicant
Stryker
47900 Bayside Pkwy.
Freemont,  CA  94538
Applicant Contact Rhoda Santos
Correspondent
Stryker
47900 Bayside Pkwy.
Freemont,  CA  94538
Correspondent Contact Rhoda Santos
Regulation Number870.1200
Classification Product Code
DQO  
Subsequent Product Code
DQY  
Date Received08/06/2019
Decision Date 11/22/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-