Company ยท US
Shiley, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1993. Name variants (Inc, Corp, punctuation) are merged.
174510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 21 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 14 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 13 |
| CAC | Apparatus, Autotransfusion | 11 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 11 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 10 |
| LFJ | Catheter, Subclavian | 7 |
| BTR | Tube, Tracheal (W/Wo Connector) | 5 |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 5 |
| DXE | Catheter, Embolectomy | 5 |
| DTP | Defoamer, Cardiopulmonary Bypass | 4 |
| KRI | Accessory Equipment, Cardiopulmonary Bypass | 4 |
| DQO | Catheter, Intravascular, Diagnostic | 3 |
| DQR | Cannula, Catheter | 3 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 3 |
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 3 |
| DWB | Pump, Blood, Cardiopulmonary Bypass, Roller Type | 3 |
| FLL | Continuous Measurement Thermometer | 3 |
| JOH | Tube Tracheostomy And Tube Cuff | 3 |
| CCE | Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 18, 1993 | K920594 | SHILEY PERFUSION TUBING SETS Shiley, Inc. | DTM |
| Nov 27, 1991 | K910991 | SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM Shiley, Inc. | CAC |
| Aug 9, 1991 | K911876 | SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200 Shiley, Inc. | DTN |
| Apr 9, 1991 | K910923 | BCD ADVANCED Shiley, Inc. | DTR |
| Jan 14, 1991 | K901548 | BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS Shiley, Inc. | CCC |
| Oct 2, 1990 | K903435 | SHILEY SPECIALIZED TRACHEOSTOMY TUBE Shiley, Inc. | JOH |
| Jul 3, 1990 | K901624 | SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY. Shiley, Inc. | DTZ |
| Jun 11, 1990 | K901250 | PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR Shiley, Inc. | DTZ |
| Jun 11, 1990 | K901249 | PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR Shiley, Inc. | DTZ |
| May 10, 1990 | K900797 | STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR Shiley, Inc. | DXS |
| Apr 23, 1990 | K900548 | SHILEY PHONATION VALVE Shiley, Inc. | BTO |
| Apr 10, 1990 | K900753 | SHILEY VEIN IRRIGATION CANNULA (BEVELED & BLUNT) Shiley, Inc. | DWF |
| Apr 10, 1990 | K900186 | BONCHEK-SHILEY CARDIAC JACKET W/RECIRCULATION SET Shiley, Inc. | DWJ |
| Mar 28, 1990 | K900339 | HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES Shiley, Inc. | DTS |
| Mar 28, 1990 | K894784 | MODIFIED SHILEY FEMORAL VENOUS CANNULA Shiley, Inc. | DQR |
| Feb 28, 1990 | K893711 | DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR Shiley, Inc. | DTN |
| Nov 28, 1989 | K895150 | CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING Shiley, Inc. | CCE |
| Nov 28, 1989 | K895149 | NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY Shiley, Inc. | CCE |
| Oct 27, 1989 | K895388 | SHILEY ELBOW 15MM SWIVEL CONNECTOR Shiley, Inc. | BZA |
| Oct 20, 1989 | K894668 | MODIFIED SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM Shiley, Inc. | CAC |
| Oct 20, 1989 | K894630 | SHILEY PLEXUS(TM) ADULT HOLLOW FIBER OXYGENATOR Shiley, Inc. | DTZ |
| Oct 12, 1989 | K894681 | REVISED LABELING FOR ARTERIAL EMBOLECTOMY CATHETER Shiley, Inc. | DXE |
| Aug 15, 1989 | K894294 | DIDECO-SHILEY UNIVERSAL Y Shiley, Inc. | CAC |
| Jul 20, 1989 | K890194 | SHILEY SPECIALIZED TRACHEOSTOMY TUBE Shiley, Inc. | JOH |
| Jul 14, 1989 | K892446 | SHILEY EQUIPMENT SUPPORT CARTS ESC-002 & ESCB-02 Shiley, Inc. | KRD |
| May 5, 1989 | K884564 | SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM-PROGRAMM Shiley, Inc. | CAC |
| May 1, 1989 | K890980 | MODIFIED STOCKERT-SHILEY VENOUS CATHETER Shiley, Inc. | DWF |
| Apr 12, 1989 | K890904 | MODIFIED STOCKERT-SHILEY CAPS MULTI. ROLLER PUMP Shiley, Inc. | DWB |
| Jan 30, 1989 | K884872 | DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR Shiley, Inc. | DTN |
| Jan 17, 1989 | K884730 | SHILEY PERC TRACHEOSTOMY SYSTEM Shiley, Inc. | BTO |
| Dec 27, 1988 | K884393 | MODIFIED SHILEY FEMORAL ARTERIAL CANNULA Shiley, Inc. | DWF |
| Sep 26, 1988 | K883332 | MAST FOR BASIC HEATER-COOLER UNIT 16-09-00 Shiley, Inc. | DTR |
| Sep 26, 1988 | K883331 | BASIC HEATER-COOLER UNIT W/MAST, 115/110V 16-21-10 Shiley, Inc. | DTR |
| Sep 26, 1988 | K883330 | BASIC HEATER-COOLER UNIT, 115/100V 16-02-20 Shiley, Inc. | DTR |
| Jul 8, 1988 | K881692 | DIDECO-SHILEY FLUID COLLECTION BAG Shiley, Inc. | CAC |
| Jul 6, 1988 | K881733 | SHILEY FEMORAL CORONARY PERFUSION CATHETER Shiley, Inc. | DWF |
| Jul 5, 1988 | K881734 | SHILEY FEMORAL LEFT VENTRICULAR VENT CATHETER Shiley, Inc. | DWF |
| Jul 5, 1988 | K881691 | PREASSEMBLED SURGICAL WASH SET 122,175,225,375AA Shiley, Inc. | DWF |
| Jun 27, 1988 | K881683 | DIDECO-SHILEY AUTOTRANS BT 795/AA Shiley, Inc. | CAC |
| Jun 9, 1988 | K881073 | SHILEY FEMORAL CANNULAE INTRODUCER KIT Shiley, Inc. | DRE |
| May 31, 1988 | K881074 | SHILEY FEMORAL VENOUS CANNULA Shiley, Inc. | DWF |
| May 31, 1988 | K881072 | SHILEY FEMORAL ARTERIAL CANNULA Shiley, Inc. | DWF |
| May 24, 1988 | K881006 | STOCKERT-SHILEY BUBBLE MONITOR 23-23-01 Shiley, Inc. | DRY |
| May 11, 1988 | K880663 | SHILEY BCD PLUS HEAT EXCHANGER Shiley, Inc. | DTR |
| May 4, 1988 | K881421 | DIDECO-SHILEY FEED TUBE SUPPORT ARMS AND HOOK Shiley, Inc. | CAC |
| Apr 27, 1988 | K881290 | MODIFIED SHILEY DUAL LUMEN SUBCLAVIAN CANNULA Shiley, Inc. | LFJ |
| Mar 9, 1988 | K880614 | SHILEY DISP. CANNULA CUFFLESS TRACEOSTOMY TUBE Shiley, Inc. | BTO |
| Feb 12, 1988 | K880247 | MODIFIED SHILEY LOW PRESSURE CUFFED TRACHEO. TUBES Shiley, Inc. | BTO |
| Sep 30, 1987 | K872719 | EXPANDED USE OF HARDSHELL VENOUS RESERV. W/FILTER Shiley, Inc. | DTN |
| Sep 23, 1987 | K872722 | EXPANDED USE FOR SHILEY 3L CARDF PLUS Shiley, Inc. | DTN |
Newest 50 of 174.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||