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 K131687
Device Name 6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET
Applicant
Medical Components, Inc.
1499 Delp Dr.
Harleysville,  PA  19438
Applicant Contact JESSICA LEO
Correspondent
Medical Components, Inc.
1499 Delp Dr.
Harleysville,  PA  19438
Correspondent Contact JESSICA LEO
Regulation Number880.5970
Classification Product Code
LJS  
Date Received06/10/2013
Decision Date 08/16/2013
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
Predetermined Change
Control Plan Authorized		 No
-
-