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 Port & Catheter, Implanted, Subcutaneous, Intravascular
510(k) Number K130576
Device Name CELSITE IMPLANTABLE ACCESS PORT SYSTEMS
Applicant
B. Braun Interventional Systems, Inc.
3100 W. Lake St., Suite 420
Minneapolis,  MN  55416
Applicant Contact AMBER KINGSTON
Correspondent
B. Braun Interventional Systems, Inc.
3100 W. Lake St., Suite 420
Minneapolis,  MN  55416
Correspondent Contact AMBER KINGSTON
Regulation Number880.5965
Classification Product Code
LJT  
Date Received03/05/2013
Decision Date 04/02/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-