• 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 port & catheter, implanted, subcutaneous, intravascular
510(k) Number K031844
Device Name VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-238
Original Applicant
BOSTON SCIENTIFIC CORP.
10 glens falls technical park
glens falls,  NY  12801 -3864
Original Contact jodi lynn greenizen
Regulation Number880.5965
Classification Product Code
LJT  
Date Received06/16/2003
Decision Date 07/15/2003
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
Recalls CDRH Recalls
-
-