Shiley, Inc.
United StatesFDA applicant, unverified
- Devices
- 175
What Shiley, Inc. makes
Shiley, Inc. manufactures cardiovascular surgical devices, including venous occlusion clamps, heater-cooler units, Y-connectors with rotators, cardiotomy reservoirs, venous reservoirs, embolism removal catheters, arterial cannulas, mechanical heart valves, cardioplegia adaptors, extracorporeal circulation pumps, blood filters, and remote control modules for intracardiac procedures.
The company’s products are regulated under FDA classifications, with devices spanning Class I, Class II, and Class III. Authorisation records include 510(k) clearances and Premarket Approval Applications (PMA). The manufacturer 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
Shiley Disp. Cannula Cuffless Traceostomy Tube Ref K880614
Active Regimes: 510(k) Registry: 510(k) ClassClass:II3-Day Bioindicator Release Process For Ref K833830
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIBlood Oxygenator 5070 Ref K831894
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIShiley Cricothyrotomy Tube Ref K781639
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIIrrigation Catheter Ref K780788
Active Regimes: 510(k) Registry: 510(k) ClassClass:IDideco-Shiley Feed Tube Support Arms And Hook Ref K881421
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Ionescu-Shiley Low Porosity Aortic Graft Ref K831880
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIShiley Phonation Valve Ref K900548
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIShiley Hardshell Venous Reservoir W/Int Ref K843232
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Shiley Disposable Cannula Trach. Tube Ref K811447
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Multipro Catheter Ref K841797
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIShiley Therapeutic Autotransfusion System Ref K910991
Active Regimes: 510(k) Registry: 510(k) ClassClass:II3-Day Bioindicator Release For Steril Ref K833831
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIShiley Perc Tracheostomy System Ref K884730
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIPlexus 3.5(Tm) Pediatric Hollow Fiber Oxygenator Ref K901249
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIShiley Silicone Sual Lumen Subclavian Cannual Ref K852070
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIShiely Duel Lumen Subclavian Cannula Ref K822134
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIShiley Specialized Tracheostomy Tube Ref K903435
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIShiley Low Pressure Thin-Cuffed Trach Ref K811033
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIShiley Femoral Venous Cannula Ref K881074
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Oxygenator, Bubble Ref K772237
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Shiley Vein Irrigation Cannula (Beveled & Blunt) Ref K900753
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISchneider-Shiley Guide Wire Ref K864787
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIPuig Massana-Shiley Annuloplasty Ring Ref K821261
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIModified Stockert-Shiley Venous Catheter Ref K890980
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIShiley Cardioplegic Solution Del Sets Ref K791947
Active Regimes: 510(k) Registry: 510(k) ClassClass:IITetraflex Integrally Supported Ptfe Ref K831822
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIShiley Bcd Plus Heat Exchanger Ref K880663
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIShiley Pts Chest Drainage Autotransfusion Set Ref K872720
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIShiley Temperature Monitor Ref K802147
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIShiley M2000 Membrane Oxygenator Ref K833253
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIBcd Advanced Ref K910923
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIMast For Basic Heater-Cooler Unit 16-09-00 Ref K883332
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIIonescu-Shiley Pericardial Patch Ref K801764
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIShiley 3l Cardf Plus Ref K832811
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIShiley Multipro Catheter Ref K832044
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Stockert-Shiley Bubble Monitor 23-23-01 Ref K881006
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIJacket & Set Ref K823533
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIModified Silicone Dual Lumen Subclavian Cannula Ref K863697
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISchneider-Shiley Wire Torquer Ref K861606
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIShiley Dispos. Cannula Fenestrated Low Ref K843729
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIShiley Arterial Filter Ref K811379
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIStockert Shiley Dual Pressure Control Module Xr Ref K900797
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIPlexus 2(Tm) Infant Hollow Fiber Oxygenator Ref K901250
Active Regimes: 510(k) Registry: 510(k) ClassClass:II
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