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 K853981
Device Name INFUSAID INFUSE-A-PORT (MODIFIED)
Applicant
Intermedics/Infusaid, Inc.
1400 Providence Hwy.
Norwood,  MA  02062
Applicant Contact VINCENT A BUCCI
Correspondent
Intermedics/Infusaid, Inc.
1400 Providence Hwy.
Norwood,  MA  02062
Correspondent Contact VINCENT A BUCCI
Regulation Number880.5965
Classification Product Code
LJT  
Date Received09/27/1985
Decision Date 12/18/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-