Medical Device Manufacturer · US , Mchenry , IL

Scimed Life Systems, Inc. - FDA 510(k) Cleared Devices

109 submissions · 108 cleared · Since 1977
109
Total
108
Cleared
0
Denied
109 devices
76-100 of 109
Cleared Nov 22, 1991
SCIMED 8 FR. TRIGUIDEFLEX GUIDING CATHETERS
K913830 · DQY
Cardiovascular · 88d
Cleared Nov 22, 1991
SCIMED 7FR AND 8FR TRIGUIDE GUIDING CATHETERS
K914312 · DQO
Cardiovascular · 57d
Cleared Aug 30, 1991
SCIMED 7 FR. & 8 FR.
K913364 · DQO
Cardiovascular · 32d
Cleared Aug 12, 1991
SCIMED OPTAMUM OPERATIVE PERIPHERAL ANGIOPLAS CATH
K911870 · LIT
Cardiovascular · 108d
Cleared Feb 11, 1991
SCIMD 7 FR. TRIGUIDE GUIDING CATHETER
K905499 · DQO
Cardiovascular · 66d
Cleared Feb 07, 1991
SCIMED OPTAMUM OPER PERIPHERAL ANGIOPLASTY CATH
K910155 · LIT
Cardiovascular · 24d
Cleared Jun 28, 1990
SCIMED CORONARY GUIDING CATHETER
K895437 · DQO
Cardiovascular · 293d
Cleared Jan 09, 1990
THE PILOT SCIMED TORQUE DEVICE
K896108 · LOX
Cardiovascular · 78d
Cleared Sep 21, 1989
SCIMED ULTROX TRUE MEMBRANE OXYGEN SYST, ULTROX II
K894103 · DTZ
Cardiovascular · 104d
Cleared Apr 03, 1989
SCIMED ECMOTHERM(TM) HEAT EXCHANGER
K884560 · DTR
Cardiovascular · 154d
Cleared Oct 06, 1988
SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS RESERVOIR
K882380 · DTN
Cardiovascular · 119d
Cleared Sep 26, 1988
SCIMED MEMBRANE OXYGENATOR, MODEL 0600-2A
K883053 · DTZ
Cardiovascular · 69d
Cleared Sep 26, 1988
SCIMED ULTROX TRUE MEMBRANE OXY. ULTROX I & II
K883054 · DTZ
Cardiovascular · 69d
Cleared Sep 16, 1988
SCIMED R30 SILICONE ASSIST RESERVOIR
K882720 · DTN
Cardiovascular · 77d
Cleared Apr 28, 1988
SCIMED MODELS P-7-14 AND A-19-38 HEAT EXCHANGERS
K880451 · DTR
Cardiovascular · 86d
Cleared Feb 29, 1988
SCIMED INFLATION DEVICE, MODEL SM 2000
K875064 · LIT
Cardiovascular · 82d
Cleared Nov 25, 1986
SCIMED MEMBRANE OXYGENATOR SYSTEM - ECMO
K863476 · DTZ
Cardiovascular · 77d
Cleared Sep 23, 1986
SCIMED II-SM25 MEMBRANE OXYGENATOR SYSTEM
K862918 · DTZ
Cardiovascular · 53d
Cleared Feb 26, 1986
MODIFIED MODEL SC4000(F) CARDIOTOMY RESERVOIR
K855049 · DTP
Cardiovascular · 71d
Cleared Apr 10, 1985
SCIMED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILAT
K850075 · LIT
Cardiovascular · 91d
Cleared Apr 10, 1985
MILLS OPERATIVE PERIPHERAL ANGIOPLASTY CATHETER
K850760 · LIT
Cardiovascular · 44d
Cleared Jan 08, 1985
SCIMED II MEMBRANE OXYGENATOR SYSTEM
K843956 · DTZ
Cardiovascular · 91d
Cleared Oct 23, 1984
MILLS OPERATIVE PERIPHERAL ANGIOPLASTY
K841961 · LIT
Cardiovascular · 162d
Cleared Oct 23, 1984
SCIMED PM200 INFLATION MANOMETER
K843448 · MAV
Cardiovascular · 48d
Cleared Apr 24, 1984
SCIMED MODEL SC4000
K840610 · DTP
Cardiovascular · 71d

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