Medical Device Manufacturer · US , Santa Clara , CA

Guidant Corp. - FDA 510(k) Cleared Devices

71 submissions · 56 cleared · Since 1997
71
Total
56
Cleared
0
Denied
71 devices
51-71 of 71
Cleared Jun 09, 1999
COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331
K991102 · DTL
Cardiovascular · 69d
Cleared Apr 30, 1999
GUIDANT MEGALINK BILIARY STENT, MODEL FG1002949-58
K991032 · FGE
Gastroenterology & Urology · 32d
Cleared Apr 29, 1999
HI-TORQUE BALANCE TREK GUIDE WIRE
K991152 · DQX
Cardiovascular · 23d
Cleared Mar 25, 1999
ACS HI-TORQUE CROSS IT 100XT, 200XT AND 300XT GUIDE WIRES WITH HYDROCOAT...
K990639 · DQX
Cardiovascular · 27d
Cleared Mar 23, 1999
STANDARD 0.025 STRAIGHT, STANDARD 0.025 ANGLED, STANDARD 0.032 STRAIGHT,...
K983346 · DQX
Cardiovascular · 181d
Cleared Mar 08, 1999
ACS HI-TORQUE WIGGLE GUIDE WIRE WITH MICROGLIDE COATING
K984394 · DQX
Cardiovascular · 90d
Cleared Mar 03, 1999
GUIDANT MEGALINK BILIARY STENT, MODEL #'S 1002949-18, 1002949-28, 1002949-38
K983075 · FGE
Gastroenterology & Urology · 182d
Cleared Dec 30, 1998
RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, MODEL #'S 1003006-20,...
K983055 · LIT
Cardiovascular · 120d
Cleared Nov 10, 1998
HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282
K982876 · DQX
Cardiovascular · 88d
Cleared Nov 10, 1998
ACS HT BALANCE MIDDLEWEIGHT GUIDE WIRE
K983033 · DQX
Cardiovascular · 71d
Cleared Sep 11, 1998
ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K982083 · DQX
Cardiovascular · 88d
Cleared Jul 15, 1998
ACS HI-TORQUE CROSS-IT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING PRODUCT...
K981381 · DQX
Cardiovascular · 90d
Cleared Apr 24, 1998
ACS HI-TORQUE SUPER SPORT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K980294 · DQX
Cardiovascular · 87d
Cleared Mar 20, 1998
ACS HI-TORQUE WHOLEY SUPRA CORE GUIDE WIRE
K980119 · DQX
Cardiovascular · 66d
Cleared Mar 13, 1998
HI-TORQUE FLOPPY GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE...
K974773 · DQX
Cardiovascular · 81d
Cleared Dec 12, 1997
HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, ACS...
K973494 · DQX
Cardiovascular · 88d
Cleared Sep 26, 1997
ACS VIKING GUIDING CATHETER
K972484 · DQY
Cardiovascular · 86d
Cleared Sep 17, 1997
ACS HI-TORQUE RULER GUIDE WIRE
K972290 · DQX
Cardiovascular · 90d
Cleared Aug 25, 1997
ACS HI-TORQUE ALL STAR 0.014 GUIDE WIRE WITH MICROGLIDE COATING
K972142 · DQX
Cardiovascular · 80d
Cleared Jul 09, 1997
ASC BALANCE MIDDLEWEIGHT GUIDE WIRE
K971815 · DQX
Cardiovascular · 54d
Cleared Apr 24, 1997
VANTAGE PERIPHERAL DILATATION CATHETER
K965183 · LIT
Cardiovascular · 121d
Filters