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
- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Ionescu-Shiley Valve Holder & Handle Ref K813276
Active Regimes: 510(k) Registry: 510(k) ClassClass:I- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Dideco-Shiley Preassembled Surgical Wash Set Ref K872161
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIShiley Femoral Left Ventricular Vent Catheter Ref K881734
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIShiley 3l Cardiotomy Reservoir Ref K853503
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIShiley S-100A (Adult) Blood Oxygenator Ref K810470
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIShiley Venous Reservoir Ref K842337
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIIonescu-Shiley Pericardial Xenograft (Isu) Ref K871596
Active Regimes: 510(k) Registry: 510(k) ClassClass:I3-Day Bioindicator Release For Respir Ref K833832
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIStockert-Shiley Universal Level Sensor Ref K843802
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIDisposable Temperature Probe Ref K821244
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIShiley Coronary Cardioplegia Adaptor Ref K843542
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIVenous Reservoir Ref K832924
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Shiley Plexus(Tm) Adult Hollow Fiber Oxygenator Ref K894630
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISchneider-Shiley Inflation Syringes Ref K861607
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Shiley Equipment Support Carts Esc-002 & Escb-02 Ref K892446
Active Regimes: 510(k) Registry: 510(k) ClassClass:IILal Test Release & Bonchek Car/Jacket Ref K833555
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Shiley Dispos. Temp. Probes Ref K833981
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
Shiley Pressure Relief Adapter Pra Ref K792265
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIModified Shiley Femoral Arterial Cannula Ref K884393
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIShiley Silicone Dual Lumen Subclavian Cannula Ref K861174
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Shiley Laryngectomy Tube Ref K821993
Active Regimes: 510(k) Registry: 510(k) ClassClass:IStockert-Shiley Caps Hlm Interface Ref K863541
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIPatch Ref K823345
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIDideco-Shiley Autotrans Bt 795/Aa Ref K881683
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIShiley Dispos. Decannulation Plug W/Sw/ Ref K843730 Open recall
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIDispos. Low Press. Cuffed Tracheostomy Ref K840539
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Hood, Infant Oxygen Ref K780220
Active Regimes: 510(k) Registry: 510(k) ClassClass:IShiley Femoral Cannulae Introducer Kit Ref K881073
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIShiley Arterial Filter W/40 Micron Scree Ref K812742
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIShiley Specialized Tracheostomy Tube Ref K890194
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIStockert-Shiley Multiflow Roller Pump Module Ref K861714
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIIonescu-Shiley Composite Conduit-Pulmoni Ref K790425
Active Regimes: 510(k) Registry: 510(k) ClassClass:—Cardf Ref K823731
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIPuig Massana-Shiley Annuloplasty Ring Ref K801879
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIExpanded Use For Shiley 3l Cardf Plus Ref K872722
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIShiley Plexus(R) Venous Reservoir, PVR1200 Ref K911876
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIShiley Utility Reservoir Ref K802119
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Modified Shiley Dual Lumen Subclavian Cannula Ref K881290
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISechrist Air-Oxygen Mixer & Ancillary Ref K841789
Active Regimes: 510(k) Registry: 510(k) ClassClass:II
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