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FDA 510(k) Applications Submitted by Nadine Smith
FDA 510(k) Number
Submission Date
Device Name
Applicant
K090509
02/26/2009
FOXCROSS .035 PTA CATHETER 14 MM X 20MM X 80 CM, MODEL 10342-20, FOXCROSS .035 PTA CATHETER
ABBOTT VASCULAR-VASCULAR SOLUTIONS
K130548
03/04/2013
EPICAGE INTERBODY FUSION DEVICE
ALPHATEC SPINE, INC.
K081417
05/20/2008
FOXCROSS PTA CATHETER
ABBOTT VASCULAR INC.
K092286
07/29/2009
FOX SV PTA CATHETER
Abbott Vascular
K063481
11/17/2006
MODIFICATION TO RX HERCULINK ELITE BILIARY STENT SYSTEM
ABBOTT VASCULAR INC.
K123623
11/23/2012
ILLICO MIS POSTERIOR FIXATION SYSTEM
ALPHATEC SPINE, INC.
K083706
12/15/2008
HI-TORQUE VERSACORE GUIDE WIRE
Abbott Vascular
K083713
12/15/2008
.035 LOC GUIDE WIRE EXTENSION
Abbott Vascular
K083732
12/16/2008
TAD AND TAD II TAPERED GUIDE WIRES
Abbott Vascular
K083738
12/16/2008
HI-TORQUE FLEX-T GUIDE WIRE, MODELS 1012067-01, 02, 03, 04 AND 05
Abbott Vascular
K143740
12/30/2014
Battalion Universal Spacer System
ALPHATEC SPINE, INC.
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