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 K983544
Device Name VYGON DOUBLE LUMEN PICC-CATHETERS (4FR. AND 5FR.)
Applicant
Vygon Corp.
1129 Bloomfield Ave.
West Cadwell,  NJ  07006
Applicant Contact ANNEMARIE CESARIO
Correspondent
Vygon Corp.
1129 Bloomfield Ave.
West Cadwell,  NJ  07006
Correspondent Contact ANNEMARIE CESARIO
Regulation Number880.5970
Classification Product Code
LJS  
Date Received10/09/1998
Decision Date 01/13/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-