Medical Device Manufacturer · US , East Rutherford , NJ

Vygon Corp. - FDA 510(k) Cleared Devices

48 submissions · 46 cleared · Since 1985
48
Total
46
Cleared
0
Denied
FDA 510(k) Regulatory Record - Vygon Corp. General Hospital
25 devices
1-25 of 25
Cleared Nov 30, 2007
MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039
K070705 · FOZ
General Hospital · 261d
Cleared Sep 29, 2006
MULTICATH EXPERT
K061250 · FOZ
General Hospital · 148d
Cleared Sep 15, 2006
LIFECATH S PICC AND MIDLINE CATHETER
K062425 · LJS
General Hospital · 28d
Cleared Apr 05, 2006
VYGON LEADER-FLEX
K052564 · FOZ
General Hospital · 198d
Cleared Mar 02, 2006
VYGON LATEX FREE BIONECTOR
K052881 · FOZ
General Hospital · 141d
Cleared Aug 19, 2005
VYGON NUTRILINE CATHETERS
K051690 · LJS
General Hospital · 57d
Cleared Sep 09, 2004
PREMICATH, 1261.205
K041468 · LJS
General Hospital · 99d
Cleared Aug 03, 2000
VYGON 2 FR EPICUTANEO PUR-CATHETER
K993052 · LJS
General Hospital · 325d
Cleared Aug 03, 2000
VYGON LIFECATH-PICC (PUR) CATHETERS (SINGLE AND DOUBLE LUMEN 3FR, 4FR, 4.5FR,...
K993442 · LJS
General Hospital · 296d
Cleared Jan 13, 1999
VYGON DOUBLE LUMEN PICC-CATHETERS (4FR. AND 5FR.)
K983544 · LJS
General Hospital · 96d
Cleared Sep 09, 1997
VYGON UMBILICAL CATHETHER INSERTION TRAY
K963196 · FOZ
General Hospital · 390d
Cleared Jun 02, 1997
VYGON MULTI-DOSE VIAL ADAPTER & BIONECTOR
K963571 · FMI
General Hospital · 270d
Cleared Feb 14, 1997
VYGON BIONECTOR WITH EXTENSION SET
K963981 · FPA
General Hospital · 134d
Cleared Jun 17, 1996
VYGON PREMI-CATH - LONG TERM CATHETER
K954302 · LJS
General Hospital · 278d
Cleared May 09, 1996
VYGON LIFEVAC MID-LINE TRAY
K954112 · FOZ
General Hospital · 283d
Cleared Apr 22, 1996
5 FR PICC-LINE CATHETER
K954638 · LJS
General Hospital · 199d
Cleared Jun 26, 1995
BIONECTOR
K941678 · FOZ
General Hospital · 447d
Cleared Oct 26, 1992
VYGON POLYURETHANE VENOUS/ARTERIAL XRO UMBIL. CATH
K921352 · FOS
General Hospital · 221d
Cleared Oct 26, 1992
VYGON XRO VENOUS/ARTERIAL UMBILICAL CATHETER
K921374 · FOS
General Hospital · 221d
Cleared Mar 07, 1991
VYGON LIFEVAC PICC
K903648 · LJS
General Hospital · 206d
Cleared Aug 10, 1990
MULTICATH PLACEMENT KIT
K901640 · FOZ
General Hospital · 123d
Cleared Apr 23, 1990
EPICUTANEO-CAVA CATHETER CODE 2184
K897168 · LJS
General Hospital · 117d
Cleared Sep 29, 1988
LECTROSPIRAL
K883612 · FPA
General Hospital · 38d
Cleared May 21, 1985
XRO UMBILICAL CATHETER-CODE 270
K851005 · FOS
General Hospital · 70d
Cleared May 03, 1985
VYGON EXCHANGE TRANSFUSION TRAY 275.00
K851477 · BRZ
General Hospital · 18d
Filters