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, therapeutic, long-term greater than 30 days
510(k) Number K170934
Device Name C3 Wave System
Applicant
Medical Components, Inc (Dba Medcomp_
1499 Delp Drive
Harleysville,  PA  19438
Applicant Contact Courtney Nix
Correspondent
Medical Components, Inc (Dba Medcomp_
1499 Delp Drive
Harleysville,  PA  19438
Correspondent Contact Courtney Nix
Regulation Number880.5970
Classification Product Code
LJS  
Date Received03/30/2017
Decision Date 12/06/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-