510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Shiley, Inc.

Mchenry, IL, US

Shiley, Inc. appears in FDA device records in Mchenry, IL. FDA records list 174 510(k) clearances between and , 6 PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
174
PMA records
6
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 174

FDA records hold 174 510(k) clearances for Shiley, Inc. between 1976 and 1993. The busiest year on record is 1986, with 25. The most recent is 1993, with 1.

Clearances by year, as a table
510(k) clearance decisions for Shiley, Inc., by decision year
YearClearances
19761
19773
19787
197910
19806
198111
19826
198312
198423
19855
198625
198717
198818
198914
199011
19914
19931
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K920594SHILEY PERFUSION TUBING SETSDTMSubstantially Equivalent
K910991SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEMCACSubstantially Equivalent
K911876SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200DTNSubstantially Equivalent
K910923BCD ADVANCEDDTRSubstantially Equivalent
K901548BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GASCCCSubstantially Equivalent
K903435SHILEY SPECIALIZED TRACHEOSTOMY TUBEJOHSubstantially Equivalent
K901624SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY.DTZSubstantially Equivalent
K901250PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATORDTZSubstantially Equivalent
K901249PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATORDTZSubstantially Equivalent
K900797STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XRDXSSubstantially Equivalent
K900548SHILEY PHONATION VALVEBTOSubstantially Equivalent
K900753SHILEY VEIN IRRIGATION CANNULA (BEVELED & BLUNT)DWFSubstantially Equivalent
K900186BONCHEK-SHILEY CARDIAC JACKET W/RECIRCULATION SETDWJSubstantially Equivalent
K900339HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLESDTSSubstantially Equivalent
K894784MODIFIED SHILEY FEMORAL VENOUS CANNULADQRSubstantially Equivalent
K893711DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIRDTNSubstantially Equivalent
K895150CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORINGCCESubstantially Equivalent
K895149NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SYCCESubstantially Equivalent
K895388SHILEY ELBOW 15MM SWIVEL CONNECTORBZASubstantially Equivalent
K894668MODIFIED SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEMCACSubstantially Equivalent
K894630SHILEY PLEXUS(TM) ADULT HOLLOW FIBER OXYGENATORDTZSubstantially Equivalent
K894681REVISED LABELING FOR ARTERIAL EMBOLECTOMY CATHETERDXESubstantially Equivalent
K894294DIDECO-SHILEY UNIVERSAL YCACSubstantially Equivalent
K890194SHILEY SPECIALIZED TRACHEOSTOMY TUBEJOHSubstantially Equivalent
K892446SHILEY EQUIPMENT SUPPORT CARTS ESC-002 & ESCB-02KRDSubstantially Equivalent
K884564SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM-PROGRAMMCACSubstantially Equivalent
K890980MODIFIED STOCKERT-SHILEY VENOUS CATHETERDWFSubstantially Equivalent
K890904MODIFIED STOCKERT-SHILEY CAPS MULTI. ROLLER PUMPDWBSubstantially Equivalent
K884872DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIRDTNSubstantially Equivalent
K884730SHILEY PERC TRACHEOSTOMY SYSTEMBTOSubstantially Equivalent
K884393MODIFIED SHILEY FEMORAL ARTERIAL CANNULADWFSubstantially Equivalent
K883332MAST FOR BASIC HEATER-COOLER UNIT 16-09-00DTRSubstantially Equivalent
K883331BASIC HEATER-COOLER UNIT W/MAST, 115/110V 16-21-10DTRSubstantially Equivalent
K883330BASIC HEATER-COOLER UNIT, 115/100V 16-02-20DTRSubstantially Equivalent
K881692DIDECO-SHILEY FLUID COLLECTION BAGCACSubstantially Equivalent
K881733SHILEY FEMORAL CORONARY PERFUSION CATHETERDWFSubstantially Equivalent
K881734SHILEY FEMORAL LEFT VENTRICULAR VENT CATHETERDWFSubstantially Equivalent
K881691PREASSEMBLED SURGICAL WASH SET 122,175,225,375AADWFSubstantially Equivalent
K881683DIDECO-SHILEY AUTOTRANS BT 795/AACACSubstantially Equivalent
K881073SHILEY FEMORAL CANNULAE INTRODUCER KITDRESubstantially Equivalent
K881074SHILEY FEMORAL VENOUS CANNULADWFSubstantially Equivalent
K881072SHILEY FEMORAL ARTERIAL CANNULADWFSubstantially Equivalent
K881006STOCKERT-SHILEY BUBBLE MONITOR 23-23-01DRYSubstantially Equivalent
K880663SHILEY BCD PLUS HEAT EXCHANGERDTRSubstantially Equivalent
K881421DIDECO-SHILEY FEED TUBE SUPPORT ARMS AND HOOKCACSubstantially Equivalent
K881290MODIFIED SHILEY DUAL LUMEN SUBCLAVIAN CANNULALFJSubstantially Equivalent
K880614SHILEY DISP. CANNULA CUFFLESS TRACEOSTOMY TUBEBTOSubstantially Equivalent
K880247MODIFIED SHILEY LOW PRESSURE CUFFED TRACHEO. TUBESBTOSubstantially Equivalent
K872719EXPANDED USE OF HARDSHELL VENOUS RESERV. W/FILTERDTNSubstantially Equivalent
K872722EXPANDED USE FOR SHILEY 3L CARDF PLUSDTNSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain