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 System, Catheter Control, Steerable
510(k) Number K160121
Device Name CorPath GRX System
Applicant
Corindus, Inc.
309 Waverley Oaks Rd., Suite 105
Waltham,  MA  02454
Applicant Contact Michael Douglas
Correspondent
CardioMed Device Consultants, LLC
5523 Research Park Dr., Suite 205
Baltimore,  MD  21228
Correspondent Contact Mona Advani
Regulation Number870.1290
Classification Product Code
DXX  
Date Received01/19/2016
Decision Date 10/27/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-