Scimed Life Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 111
What Scimed Life Systems, Inc. makes
Scimed Life Systems, Inc. manufactures guide catheters and guide wires for percutaneous transluminal coronary angioplasty (PTCA) procedures, including the Triguide guiding catheter series in 7FR and 8FR sizes, the Viper guide catheter, and various PTCA guide wires such as the Pursuit Exchange, Controlwire, Entre, Choice PT Plus, and Choice Plus models, some featuring hydrophilic coatings like the ICE coating on 0.014-inch wires.
The company's devices are classified as Class I and Class II medical devices and are listed in the FDA's 510(k) and PMA registries; Scimed Life Systems, Inc. is based in the United States.
AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.
DeviceDevice · Authorizations Verified Status Regime Registry Class
Scimed 10 Fr Large Lumen Triguide-Flex Guid Cath Ref K940545
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIScimed 8 French Wiseguide Guide Catheter Ref K970823
Active Regimes: 510(k) Registry: 510(k) ClassClass:II7 French Large Lumen Triguide-Plus Ref K943783
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIScimed Sceptor Ptca Guide Wire Ref K950534
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISci Med Tubing Connectors Ref K831261
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIScimed Coronary Guiding Catheter Ref K895437
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIScimd 7 Fr. Triguide Guiding Catheter Ref K905499
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIScimed Model Sc 3000 Ref K820954
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICardiotomy Reservoir SC3500F Ref K834041
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIScimed Models P-7-14 And A-19-38 Heat Exchangers Ref K880451
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Scimed Membrane Oxygenator, Model 0600-2A Ref K883053
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIScimed Avenue Coronary Guidewire Insertion Tool Ref K922410
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIModel Tp Thermistor Probe Ref K831528
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIScimed Encore(Tm) Advantage Kit/Essentials Kit Ref K925608
Active Regimes: 510(k) Registry: 510(k) ClassClass:IILuge Guide Wire Ref K973945
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Scimed En Tre' Iii Ptca Guide Wire Ref K942333
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIScimed Model SC4000 Ref K840610
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIScimed 8 Fr. Triguideflex Guiding Catheters Ref K913830
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Scimed Choice(Tm) Ptca Guide Wire Ref K943192
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISci Med Temperature Monitoring Adaptor Ref K831260
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIScimed 6 French Wiseguide Guide Catheter Ref K981788
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Scimed Ii-SM25 Membrane Oxygenator System Ref K862918
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Scimed 7 French Wiseguide Guide Catheter Ref K974684
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIScimed 6 French Expo Angiographic Catheter Ref K950731
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIScimed 6 French Micro-Max(Tm) Guide Catheter Ref K950094
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Modified Model SC4000(F) Cardiotomy Reservoir Ref K855049
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIScimed Sidewinder Tuohy-Borst Y-Adapter Ref K921577
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Scimed Maverick Pta Catheter Ref K932537
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIScimed(R) Sceptor(Tm) Ptca Guide Wire Ref K946240
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Scimed Triguide Guiding Catheter Ref K941137
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIValve, Pressure Relief, Blood Oxygenator Ref K770681
Active Regimes: 510(k) Registry: 510(k) ClassClass:IScimed 6 French Impulse Angiographic Catheters Ref K974559
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIScimed 7 Fr. & 8 Fr. Ref K913364
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIScimed(R) Chice(Tm) Exchange Ptca Guide Wire Ref K950113
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIScimed 8 French Big-Max Guide Catheter Ref K943777
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIMills Operative Peripheral Angioplasty Catheter Ref K850760
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIScimed Ecmotherm(Tm) Heat Exchanger Ref K884560
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Parametric Process Control Ref K923826
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIScimed(R) Choice(Tm) Pt Exchange Ptca Guide Wire Ref K950266
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
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