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 K080604
Device Name PRESSURE INJFECTABLE PICC
Applicant
ARROW INTERNATIONAL, INC.
2400 BERNVILLE RD.
READING,  PA  19605
Applicant Contact JULIE LAWSON
Correspondent
ARROW INTERNATIONAL, INC.
2400 BERNVILLE RD.
READING,  PA  19605
Correspondent Contact JULIE LAWSON
Regulation Number880.5970
Classification Product Code
LJS  
Date Received03/04/2008
Decision Date 06/27/2008
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
-
-