• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name catheter,intravascular,therapeutic,long-term greater than 30 days
510(k) Number K121094
Device Name MEDCOMP VASCU-PICC & MIDLINE CATHETERS
Original Applicant
MEDICAL COMPONENTS INC
1499 delp drive
harleysville,  PA  19438
Original Contact jean callow
Regulation Number880.5970
Classification Product Code
LJS  
Date Received04/10/2012
Decision Date 06/06/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
statement statement
Type Special
Reviewed by Third Party No
Combination Product No
-
-