Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart E—Cardiovascular Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- CACApparatus, Autotransfusion2Product Code
- K241236XTRA Collection sets; XTRA Sequestration set X2Cleared 510(K)
- K240426Aventus Clot Management System2Cleared 510(K)
- K240584XTRA Autotransfusion System (with XTRA Bowl sets)2Cleared 510(K)
- K231782FlowSaver Blood Return System (80-101)2Cleared 510(K)
- K221483FlowSaver Blood Return System2Cleared 510(K)
- K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)2Cleared 510(K)
- K201305Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain2Cleared 510(K)
- K210862Hemafuse System2Cleared 510(K)
- K210176FlowSaver Blood Filter2Cleared 510(K)
- K210089CATSmart, Automated Blood Processing Autotransfusion System2Cleared 510(K)
- K193361ProCell Surgical Sponge-Blood Recovery Unit2Cleared 510(K)
- K192368CATSmart2Cleared 510(K)
- K180831CATSmart2Cleared 510(K)
- K181954autoLog IQ Autotransfusion System2Cleared 510(K)
- K162423Haemonetics Cell Saver Elite/Elite+ Autotransfusion System2Cleared 510(K)
- K160735CATSmart2Cleared 510(K)
- K160197Haemonetics Cell Saver Elite Autotransfusion System2Cleared 510(K)
- K140205PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM2Cleared 510(K)
- K140197PLEUR-EVAC PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM2Cleared 510(K)
- K131553XTRA2Cleared 510(K)
- K130043PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM2Cleared 510(K)
- K120953PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM2Cleared 510(K)
- K122262ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM2Cleared 510(K)
- K120586CELL SAVER ELITE2Cleared 510(K)
- K112245XTRA2Cleared 510(K)
- K110782XVAC2Cleared 510(K)
- K101907HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM2Cleared 510(K)
- K103202PREASSEMBLED SURGICAL WASH SET2Cleared 510(K)
- K101586XTRA AUTOTRANSFUSION SYSTEM2Cleared 510(K)
- K093535AUTOLOG AUTOTRANSFUSION SYSTEM2Cleared 510(K)
- K082923PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C2Cleared 510(K)
- K060482CYTORI CELUTION CELL CONCENTRATION DEVICE2Cleared 510(K)
- K053000HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT)2Cleared 510(K)
- K043127HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM2Cleared 510(K)
- K043140EXPRESS AND OASIS CHEST DRAIN2Cleared 510(K)
- K041525HEMOVAC BLOOD REINFUSION SYSTEM2Cleared 510(K)
- K031554S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM2Cleared 510(K)
- K022167PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM2Cleared 510(K)
- K024097SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-142Cleared 510(K)
- K022489SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT45142Cleared 510(K)
- K020647DIDECO ELECTA2Cleared 510(K)
- K022348ACCESS CONCENTRATION SYSTEM, MODEL ACC-100, ACCESS DISPOSABLE SET, MODEL ADS-20002Cleared 510(K)
- K012406ACCESS SEQUESTRATION SYSTEM2Cleared 510(K)
- K014187AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM2Cleared 510(K)
- K014083HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM2Cleared 510(K)
- K012178FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW2Cleared 510(K)
- K993581HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER HAEMOLITE 2 FAMILY OF AUTOLOGOUS BLOOD RECOVER2Cleared 510(K)
- K992723ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM2Cleared 510(K)
- K991986COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH THE CRIT-LINE HEMATOCRIT SAMPLING SYSTEM OPTION2Cleared 510(K)
- K983022SMARTCELL PROCESSING SYSTEM2Cleared 510(K)
- K982660ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM2Cleared 510(K)
- K984233C.A.T.S AUTOTRANSFUSION ACCESSORIES, MODELS ATS SUCTION LINE, ATY Y-ADAPTER, AND ATO OXYGENATOR LINE2Cleared 510(K)
- K982712RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-2502Cleared 510(K)
- K982650AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS)2Cleared 510(K)
- K982241BETATRANS INTRAOP I AND II MODEL NUMBERS DS100X AND DS10XX2Cleared 510(K)
- K982755MODIFICATION OF AUTOTRANSFUSION APPARATUS (AUTOLOG)2Cleared 510(K)
- K972894AUTOTRANSFUSION APPARTUS (AUTOLOG)2Cleared 510(K)
- K974897COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET2Cleared 510(K)
- K963759DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS2Cleared 510(K)
- K963758CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE2Cleared 510(K)
- K970714STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)2Cleared 510(K)
- K970857ARGYLE AQUA-SEAL ALL PURPOSE AUTOTRANSFUSION CHEST DRAINAGE UNIT AND OPTIONAL ARGYLE AQUA-SEAL EVACUATING AUTOTRANSFUSIO2Cleared 510(K)
- K973627STANDARD VOLUME PROCESSING SET FOR THE COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM2Cleared 510(K)
- K973378C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 612Cleared 510(K)
- K971274C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM, AT1 AUTOTRANSFUSION SET, PSQ SET2Cleared 510(K)
- K963850PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM2Cleared 510(K)
- K962475ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM2Cleared 510(K)
- K962689COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH MODIFIED PLASMA RECOVERY PROGRAM (PRP)2Cleared 510(K)
- K964070DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAG2Cleared 510(K)
- K960734HAEMOCELL SYSTEM 350 OR S3502Cleared 510(K)
- K963098PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100)2Cleared 510(K)
- K960006C.A.T.S. CONTINUOUS AUTOTRANSFUSION SYSTEM2Cleared 510(K)
- K955010AUTOVAC BP SYSTE, 2000 SERIES2Cleared 510(K)
- K942844LEVEL 1 BLOOD STREAM RECOVERY SYSTEM2Cleared 510(K)
- K951592BETATRANS I AND II2Cleared 510(K)
- K953118CARACELL2Cleared 510(K)
- K952224STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)2Cleared 510(K)
- K945775BOEHRINGER AUTOVAC(R) 7900 SERIES2Cleared 510(K)
- K944232AUTOFLO INTRA-OP SHED BLOOD AUTORTRANSFUSTION SYS2Cleared 510(K)
- K942791ARGYLE AQUA-SEAL CONTINUOUS AUTOTRANSFUSION CHEST DRAINAGE UNIT2Cleared 510(K)
- K936220DIDECO VACUUM PUMP2Cleared 510(K)
- K940519DIDECO COMPACT-A AUTOTRANSFUSION SYSTEM2Cleared 510(K)
- K931899DAVOL ATS2Cleared 510(K)
- K926338PLEUR-EVAC CARDIOTOMY RESERVOIR # CR-9400 & 9400F2Cleared 510(K)
- K932093AUTOVAC CLOSED WOUND AUTOTRANSFUSION SYSTEM,7920 S2Cleared 510(K)
- K933960PLASMA RECOVERY PROGRAM FOR THE COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM2Cleared 510(K)
- K940678AUTOTRANSFUSION SUCTION RESERVOIR WITH FILTER2Cleared 510(K)
- K932890CELL SAVER 5 SYSTEM2Cleared 510(K)
- K933625BRAT 2 AUTOLOGUS BLOOD SALVAGE SYSTEM2Cleared 510(K)
- K931552DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT2Cleared 510(K)
- K931106BIOSURGE(TM) SYNCHRONOUS AUTOTRANS PROCEDURE KIT2Cleared 510(K)
- K925827IMPRAFLO(TM) POST OPERATIVE/DRAIN/REINFUS KIT/CANI2Cleared 510(K)
- K920618AUTOTRANSFUSION SUCTION SET2Cleared 510(K)
- K913247SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM2Cleared 510(K)
- K913177SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM2Cleared 510(K)
- K915130MAT MEMBRANE AUTOTRANSFUSION SYSTEM2Cleared 510(K)
- K924894AUTOVAC 7900 SERIES2Cleared 510(K)
- K920273HEMOVAC AUTOTRANSFUSION SYSTEM2Cleared 510(K)
- K914119DAVOL ORTHOPAEDIC AUTOTRANSFUSION SYSTEM2Cleared 510(K)
- K923016AUTOLOGOUS BLOOD COLLECTION SET2Cleared 510(K)
- K914053SYSTEM 3502Cleared 510(K)
- K913181AUTOLOGOUS BLOOD PROCESSING SYSTEM2Cleared 510(K)
- K913773COBE BRAT SYSTEMS WITHOUT REINFUSION PROTECTION2Cleared 510(K)
- K912956ATRIUM DUAL ATS WATER SEAL CHEST DRAIN UNIT2Cleared 510(K)
- K912609MINI-OP ATS BLOOD RECOVERY BAG, MOEL 29502Cleared 510(K)
- K912610MINI-OP ATS BLOOD RECOVERY BAG, MODEL 29552Cleared 510(K)
- K910991SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM2Cleared 510(K)
- K913684DAVOL POST-OP AUTOTRANSFUSION SYSTEM2Cleared 510(K)
- K912019ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEM2Cleared 510(K)
- K904164AUTOVAC (R) AUTOTRANSFUSION SYSTEM, 7900 MODIFIED2Cleared 510(K)
- K911656PLEUR-EVAC PLUS CONTIN. REINFUS. & AUTOINFUS. SYST2Cleared 510(K)
- K910238PORTABLE AUTO TRANSFUSION SYSTEM 5002Cleared 510(K)
- K910211ORTH-EVAC(TM) SUCTION HAND BULB MODEL NO. 01-1502Cleared 510(K)
- K904888AUTOWAND(TM) 7XXX SERIES, MODIFICATION2Cleared 510(K)
- K904794IN-LINE ATS BLOOD RECOVERY BAG2Cleared 510(K)
- K904515IMPRAFLO 3500 SERIES2Cleared 510(K)
- K904474HAEMONETICS LN 200F COLLECTION RESERVOIR2Cleared 510(K)
- K904041HAEMONETICS CELL SAVER 4 PLUS2Cleared 510(K)
- K901401DAVOL AUTOTRANSFUSION BLOOD PROCESSING SYSTEM2Cleared 510(K)
- K903392ELECTROMEDICS BT422-120 AND BT422-402Cleared 510(K)
- K900483VARIDYNE AT POSTOPERATIVE ORTHOPEDIC AUTOTRANSFU.2Cleared 510(K)
- K902713ACCESS. KIT FOR THE BIOSURGE SYNCHRONOUS AUTOTRANS2Cleared 510(K)
- K902059AUTOWAND(TM) 7XXX SERIES2Cleared 510(K)
- K902759COBE CLOSED WOUND DRAINAGE KIT2Cleared 510(K)
- K901232IMPRAFLO AUTOTRANSFUSION DEVICE2Cleared 510(K)
- K902671COBE AUTOLOGOUS BLOOD SALVAGE RESERV W/W/O FILTER2Cleared 510(K)
- K900325ORTH-EVAC TM2Cleared 510(K)
- K901138AUTOVAC(R) AUTOTRANSFUSION SYSTEM, 7900 SERIES2Cleared 510(K)
- K893218AP900/PRP MODULE AND ACCESSORIES, MODIFICATION2Cleared 510(K)
- K900299ATS Y ADAPTER CODE #24522Cleared 510(K)
- K896857SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM2Cleared 510(K)
- K896858SOLCOTRANS INTRAOPERATIVE AUTOTRANSFUSION SYSTEM2Cleared 510(K)
- K897127ATRIUM 2052 CHEST DRAIN, DUAL COLLECTION BLOOD2Cleared 510(K)
- K897126ATRIUM 2050 CHEST DRAIN BLOOD RECOVERY SYSTEM2Cleared 510(K)
- K895297AUTOTRANSFUSION RESERVIOR MODEL 7900 MODIFICATION2Cleared 510(K)
- K892443BLOOD RECOVERY/AUTOTRANSFUSION RESERVOIR ATR-29002Cleared 510(K)
- K894668MODIFIED SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM2Cleared 510(K)
- K893394ORTHOPEDIC WOUND DRAINAGE SET WITH TROCAR2Cleared 510(K)
- K894294DIDECO-SHILEY UNIVERSAL Y2Cleared 510(K)
- K893578PHARMASEAL MEDI-VAC STERILE POST-OP AUTOTRANS. SYS2Cleared 510(K)
- K893402COMPACT 2052(TM) DUAL COLLECTION BLOOD RECOVERY2Cleared 510(K)
- K892857HARVESTING TUBE2Cleared 510(K)
- K890171INLINE AUTOTRANSFUSION SYSTEM2Cleared 510(K)
- K892819AUTOTRANSFUSION DEVICE2Cleared 510(K)
- K884564SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM-PROGRAMM2Cleared 510(K)
- K884844PLEUR-EVAC(R) A-7002--ADULT/PEDIATRIC DRAINAGE2Cleared 510(K)
- K883934CELL SAVER HAEMOLITE B AUTO. BLOOD RECOVERY SYSTEM2Cleared 510(K)
- K883058SOLCOTRANS ORTHO. DRAINAGE/REINFUSION SYSTEM2Cleared 510(K)
- K883082PLEUR-EVAC(R)-A-7020-INFANT CHEST DRAIN SYSTEM2Cleared 510(K)
- K883663ATS BLOOD RECOVERY BAG2Cleared 510(K)
- K881350CBC/CONSTAVAC BLOOD CONSERVATION SYSTEM2Cleared 510(K)
- K881631BIODYNAMICS AUTOTRANSFUSION RESERVOIR2Cleared 510(K)
- K882757ARGYLE AUTOTRANSFUSION BAG2Cleared 510(K)
- K881692DIDECO-SHILEY FLUID COLLECTION BAG2Cleared 510(K)
- K881683DIDECO-SHILEY AUTOTRANS BT 795/AA2Cleared 510(K)
- K881129AUTO-VAC INTRAOPERATIVE AUTOTRANS. RESERVOIR #79042Cleared 510(K)
- K881421DIDECO-SHILEY FEED TUBE SUPPORT ARMS AND HOOK2Cleared 510(K)
- K880162PLEUR-EVAC--A-5002 CHEST DRAINAGE SYSTEM W/AUTO2Cleared 510(K)
- K873807AUTOTRANSFUSION APPARATUS2Cleared 510(K)
- K875023BIOSURGE MODEL OASYS-II2Cleared 510(K)
- K872927DAVOL INTRAOPERATIVE AUTOTRANSFUSION KIT2Cleared 510(K)
- K872590SOLCOTRANS CHEST DRAINAGE AUTOTRANSFUSION SYSTEM2Cleared 510(K)
- K872814SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM (REMOTE)2Cleared 510(K)
- K872160DIDECO-SHILEY BLOOD SEPARATION WASH BOWL2Cleared 510(K)
- K872162DIDECO-SHILEY BLOOD REINFUSION BAG2Cleared 510(K)
- K872158DIDECO-SHILEY WASTE COLLECTION BAG2Cleared 510(K)
- K871624THORA-DRAIN(R) ABT SYSTEM2Cleared 510(K)
- K871568PLEURA-GARD ATS2Cleared 510(K)
- K871847BT-795/ATS2Cleared 510(K)
- K871258BIOSURGE MODEL OASYS2Cleared 510(K)
- K864374ARGYLE SENTINEL SEAL AUTOTRANSFUSION SYSTEM2Cleared 510(K)
- K862684AUTO-VAC (TM) AUTOTRANSFUSION RESERV, MODEL 79002Cleared 510(K)
- K861677PHARMASEAL MEDI-VAC INTRA-OPER. AUTOTRANSFUS. KIT2Cleared 510(K)
- K860306BT-795/P AUTOMATED AUTOTRANS2Cleared 510(K)
- K852178EXU-BAG CSU-1200(DISPOS)CANISTER 602-2(NON-DISPOS2Cleared 510(K)
- K854301PLEUR-EVAC II AUTOTRANSFUSION SYSTEM2Cleared 510(K)
- K843821SOLCO BASLE INTRAOPERATIVE AUTOTTRNSFUS2Cleared 510(K)
- K852736BAYLOR RAPID AUTOTRANSFUSION SYSTEM2Cleared 510(K)
- K852425CELL SAVER SUCTION SYSTEM2Cleared 510(K)
- K851024PLEUR-EVAC AUTOTRANSFUSION SYSTEM -TENTATIVE2Cleared 510(K)
- K842610GUIDELINES FOR PEDIATRIC ANESTHESIA2Cleared 510(K)
- K831849PLEURAL DRAINAGE SYS #PDS-100-42Cleared 510(K)
- K831557INTRAOPERATIVE AUTOTRANSFUSION SYS2Cleared 510(K)
- K830735BT 795/A AUTOTRANS2Cleared 510(K)
- K812292AUTOTRANS BT7952Cleared 510(K)
- K812355IBM 2991 BLOOD CELL PROCESSOR MOD. 1 & 22Cleared 510(K)
- K811228SORENSON CATALOG #IFL-120S2Cleared 510(K)
- K802674RESERVOIR FOR AUTOLOGOUS BLOOD TRANSFUS.2Cleared 510(K)
- K791891ACU-MED RED MISER HEMOTHORAX BLOOD COLL.2Cleared 510(K)
- K781551TRAUMA DRAINAGE SET 72T-32TTC2Cleared 510(K)
- K781553MEDIASTINAL DRAINAGE TUBE SET MDT-36TC22Cleared 510(K)
- K781552MEDIASTINAL DRAINAGE TUBE SET MDT-32TC22Cleared 510(K)
- K781550TRAUMA DRAINAGE SET 72T-28TTC2Cleared 510(K)
- K772280RECEPTAL ATS MEDIASTINAL LINER2Cleared 510(K)
- K772196RECEPTAL ATS TRAUMA KGA1900L2Cleared 510(K)
- OEVCardiopulmonary Resuscitation Aid Kit2Product Code
- ChemistryReview Panel
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- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
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- UnknownReview Panel
ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEM
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K912019
- 510(k) Type
- Traditional
- Applicant
- GISH BIOMEDICAL, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/8/1991
- Days to Decision
- 154 days
- Submission Type
- Statement