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, Umbilical Artery
510(k) Number K851005
Device Name XRO UMBILICAL CATHETER-CODE 270
Applicant
Vygon Corp.
1 Madison St.
East Rutherford,  NJ  07073
Applicant Contact TONY J RIVERS
Correspondent
Vygon Corp.
1 Madison St.
East Rutherford,  NJ  07073
Correspondent Contact TONY J RIVERS
Regulation Number880.5200
Classification Product Code
FOS  
Date Received03/12/1985
Decision Date 05/21/1985
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
-
-