• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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 K113277
Model CDC-34052-HPK1A
Device Name ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS
Original Applicant
ARROW INTERNATIONAL, INC.
2400 bernville rd.
reading,  PA  19605
Original Contact tracy maddock
Regulation Number880.5970
Classification Product Code
LJS  
Date Received11/07/2011
Decision Date 06/21/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-