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FDA 510(k) Applications Submitted by ABBOTT VASCULAR INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K062554
08/30/2006
STARCLOSE HEX-HUB DILATOR
ABBOTT VASCULAR INC.
K001856
06/19/2000
SUPERCROSS CATHETER
ABBOTT VASCULAR INC.
K001703
06/05/2000
PERCLOSE VASCULAR SUTURE DELIVERY DEVICE
ABBOTT VASCULAR INC.
K080925
04/02/2008
FOX PLUS PTA CATHETER
ABBOTT VASCULAR INC.
K142415
08/28/2014
Hi-Torque JET Guide Wire Family
ABBOTT VASCULAR INC.
K031331
04/28/2003
WZ SELF-EXPANDING STENT TRANSHEPATIC BILIARY SYSTEM
ABBOTT VASCULAR INC.
K032929
09/22/2003
MODIFICATION TO:XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 14819, 14820, 14821, 14822, 14822
ABBOTT VASCULAR INC.
K101011
04/12/2010
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL
ABBOTT VASCULAR INC.
K122573
08/23/2012
HI-TORQUE COMMAND GUIDE WIRE FAMILY
ABBOTT VASCULAR INC.
K060902
04/03/2006
STARCLOSE INTRODUCER SET MODEL- 1002
ABBOTT VASCULAR INC.
K101648
06/11/2010
HI-TORQUE WINN GUIDE WIRE FAMILY
ABBOTT VASCULAR INC.
K102705
09/20/2010
ARMADA 14 PTA CATHETER
ABBOTT VASCULAR INC.
K091825
06/19/2009
HI-TORQUE PROGRESS GUIDE WIRE FAMILY
ABBOTT VASCULAR INC.
K081417
05/20/2008
FOXCROSS PTA CATHETER
ABBOTT VASCULAR INC.
K063481
11/17/2006
MODIFICATION TO RX HERCULINK ELITE BILIARY STENT SYSTEM
ABBOTT VASCULAR INC.
K013683
11/07/2001
MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE
ABBOTT VASCULAR INC.
K123067
10/01/2012
PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY
ABBOTT VASCULAR INC.
K021062
04/02/2002
CHITO-SEAL
ABBOTT VASCULAR INC.
K014118
12/14/2001
MODIFICATION TO SUPERCROSS CATHETER
ABBOTT VASCULAR INC.
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