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
26-50 of 71
Cleared Jan 18, 2002
MODIFICATION TO DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM
K014184 · FGE
Gastroenterology & Urology · 29d
Cleared Jan 16, 2002
HI-TOQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC...
K013833 · DQX
Cardiovascular · 58d
Cleared Jan 10, 2002
7MM EXTENDED LENGTH ENDOSCOPE,DISSECTION TIPS, MODELS VH-1111, VH-1114
K014250 · GCJ
General & Plastic Surgery · 15d
Cleared Jan 07, 2002
DYNALINK .018 BILLARY SELF-EXPANDING STENT SYSTEM
K014007 · FGE
Gastroenterology & Urology · 33d
Cleared Dec 13, 2001
HI-TOQUE WHISPER LS AND MS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K013092 · DQX
Cardiovascular · 87d
Cleared Dec 04, 2001
MODIFICATION TO VIKING OPTIMA GUIDING CATHETER
K013638 · DQY
Cardiovascular · 29d
Cleared Sep 06, 2001
VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
K012050 · DQY
Cardiovascular · 66d
Cleared Jul 26, 2001
VIKING OPTIMA GUIDING CATHETER
K012002 · DQY
Cardiovascular · 29d
Cleared Jul 18, 2001
DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM
K011881 · FGE
Gastroenterology & Urology · 30d
Cleared Jun 15, 2001
OMNILINK .035 BILIARY STENT SYSTEM
K011506 · FGE
Gastroenterology & Urology · 30d
Cleared Jun 13, 2001
AVIATOR PERIPHERAL DILATATION CATHETER
K010831 · DQY
Cardiovascular · 85d
Cleared May 08, 2001
OMNILINK .018 BILIARY STENT SYSTEM
K011039 · FGE
Gastroenterology & Urology · 33d
Cleared Apr 12, 2001
RX HERCULINK PLUS BILIARY STENT SYSTEM
K010684 · FGE
Gastroenterology & Urology · 35d
Cleared Oct 12, 2000
DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM
K002143 · FGE
Gastroenterology & Urology · 87d
Cleared Aug 24, 2000
HI-TORQUE WHISPER LS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE...
K002206 · DQX
Cardiovascular · 34d
Cleared Jun 02, 2000
VIKING OPTIMA GUIDING CATHETER
K001435 · DQY
Cardiovascular · 25d
Cleared May 17, 2000
OTW MEGALINK SDS BILLIARY STENT SYSTEM, MODELS 1005509-18, 1005510-18,...
K001222 · FGE
Gastroenterology & Urology · 30d
Cleared May 17, 2000
RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005127-13, 1005129-13,...
K001224 · FGE
Gastroenterology & Urology · 30d
Cleared Apr 12, 2000
1 OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER
K000793 · FGE
Gastroenterology & Urology · 30d
Cleared Mar 24, 2000
5F GUIDING CATHETER
K000598 · DQY
Cardiovascular · 30d
Cleared Feb 10, 2000
RX VIATRAC 14 PERIPHERAL DILATATION CATHETER
K000101 · LIT
Cardiovascular · 28d
Cleared Jan 27, 2000
RX VIATRAC 18 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL...
K993639 · LIT
Cardiovascular · 91d
Cleared Nov 17, 1999
MODIFICATION TO RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005126-13,...
K993588 · FGE
Gastroenterology & Urology · 26d
Cleared Nov 12, 1999
LEAD STYLET,MODELS 6505,6506,6507,6508
K992863 · DRB
Cardiovascular · 79d
Cleared Oct 08, 1999
RX MEGALINK SDS BILIARY STENT SYSTEM, OTW MEGALINK SDS BILIARY STENT SYSTEM
K992319 · FGE
Gastroenterology & Urology · 88d
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