Apparatus, Autotransfusion

FDA product code CAC · 192 cleared devices

Class 2 Anesthesiology

Regulation: 21 CFR 868.5830
Review panel: CV
Implant: No
Life sustaining: Yes
Third party review: No
GMP exempt: No
Clearance span: 1977-12-22 – 2024-08-16

CAC 1991-11-29

ATRIUM DUAL ATS WATER SEAL CHEST DRAIN UNIT

Applicant Atrium Medical Corp.

K number K912956

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CAC 1991-11-29

MINI-OP ATS BLOOD RECOVERY BAG, MODEL 2955

Applicant Atrium Medical Corp.

K number K912610

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CAC 1991-11-29

MINI-OP ATS BLOOD RECOVERY BAG, MOEL 2950

Applicant Atrium Medical Corp.

K number K912609

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CAC 1991-11-27

SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM

Applicant Shiley, Inc.

K number K910991

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CAC 1991-11-15

DAVOL POST-OP AUTOTRANSFUSION SYSTEM

Applicant Davol, Inc.

K number K913684

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CAC 1991-10-08

ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEM

Applicant Gish Biomedical, Inc.

K number K912019

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CAC 1991-09-06

AUTOVAC (R) AUTOTRANSFUSION SYSTEM, 7900 MODIFIED

Applicant Boehringer Laboratories

K number K904164

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CAC 1991-08-13

PLEUR-EVAC PLUS CONTIN. REINFUS. & AUTOINFUS. SYST

Applicant Pfizer Hospital Products Group, Inc.

K number K911656

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CAC 1991-06-19

PORTABLE AUTO TRANSFUSION SYSTEM 500

Applicant Electromedics, Inc.

K number K910238

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CAC 1991-04-03

ORTH-EVAC(TM) SUCTION HAND BULB MODEL NO. 01-150

Applicant Deknatel, Inc.

K number K910211

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CAC 1991-01-16

AUTOWAND(TM) 7XXX SERIES, MODIFICATION

Applicant Boehringer Laboratories

K number K904888

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CAC 1991-01-08

IN-LINE ATS BLOOD RECOVERY BAG

Applicant Atrium Medical Corp.

K number K904794

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CAC 1990-12-04

IMPRAFLO 3500 SERIES

Applicant Impra, Inc.

K number K904515

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CAC 1990-11-13

HAEMONETICS LN 200F COLLECTION RESERVOIR

Applicant Haemonetics Corp.

K number K904474

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CAC 1990-11-13

HAEMONETICS CELL SAVER 4 PLUS

Applicant Haemonetics Corp.

K number K904041

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CAC 1990-10-23

DAVOL AUTOTRANSFUSION BLOOD PROCESSING SYSTEM

Applicant Davol, Inc.

K number K901401

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CAC 1990-09-06

ELECTROMEDICS BT422-120 AND BT422-40

Applicant Electromedics, Inc.

K number K903392

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CAC 1990-08-29

VARIDYNE AT POSTOPERATIVE ORTHOPEDIC AUTOTRANSFU.

Applicant Baxter Healthcare Corp

K number K900483

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CAC 1990-07-25

ACCESS. KIT FOR THE BIOSURGE SYNCHRONOUS AUTOTRANS

Applicant Diemolding Corp.

K number K902713

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CAC 1990-07-24

AUTOWAND(TM) 7XXX SERIES

Applicant Boehringer Laboratories

K number K902059

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CAC 1990-07-18

COBE CLOSED WOUND DRAINAGE KIT

Applicant Cobe Laboratories, Inc.

K number K902759

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CAC 1990-07-18

IMPRAFLO AUTOTRANSFUSION DEVICE

Applicant Impra, Inc.

K number K901232

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CAC 1990-07-17

COBE AUTOLOGOUS BLOOD SALVAGE RESERV W/W/O FILTER

Applicant Cobe Laboratories, Inc.

K number K902671

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CAC 1990-07-03

ORTH-EVAC TM

Applicant Deknatel, Inc.

K number K900325

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CAC 1990-06-18

AUTOVAC(R) AUTOTRANSFUSION SYSTEM, 7900 SERIES

Applicant Boehringer Laboratories

K number K901138

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CAC 1990-06-12

AP900/PRP MODULE AND ACCESSORIES, MODIFICATION

Applicant Electromedics, Inc.

K number K893218

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CAC 1990-05-01

ATS Y ADAPTER CODE #2452

Applicant Artium Medical Corp.

K number K900299

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CAC 1990-04-05

SOLCOTRANS INTRAOPERATIVE AUTOTRANSFUSION SYSTEM

Applicant Solco Basle, Inc.

K number K896858

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CAC 1990-04-05

SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM

Applicant Solco Basle, Inc.

K number K896857

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CAC 1990-03-13

ATRIUM 2052 CHEST DRAIN, DUAL COLLECTION BLOOD

Applicant Atrium Medical Corp.

K number K897127

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CAC 1990-03-13

ATRIUM 2050 CHEST DRAIN BLOOD RECOVERY SYSTEM

Applicant Atrium Medical Corp.

K number K897126

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CAC 1990-03-13

AUTOTRANSFUSION RESERVIOR MODEL 7900 MODIFICATION

Applicant Boehringer Laboratories

K number K895297

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CAC 1989-11-08

BLOOD RECOVERY/AUTOTRANSFUSION RESERVOIR ATR-2900

Applicant Gish Biomedical, Inc.

K number K892443

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CAC 1989-10-20

MODIFIED SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM

Applicant Shiley, Inc.

K number K894668

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CAC 1989-10-19

ORTHOPEDIC WOUND DRAINAGE SET WITH TROCAR

Applicant Haemonetics Corp.

K number K893394

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CAC 1989-08-15

DIDECO-SHILEY UNIVERSAL Y

Applicant Shiley, Inc.

K number K894294

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CAC 1989-08-01

PHARMASEAL MEDI-VAC STERILE POST-OP AUTOTRANS. SYS

Applicant Baxter Healthcare Corp

K number K893578

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CAC 1989-06-23

COMPACT 2052(TM) DUAL COLLECTION BLOOD RECOVERY

Applicant Atrium Medical Corp.

K number K893402

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CAC 1989-06-15

HARVESTING TUBE

Applicant Conmedcorp

K number K892857

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CAC 1989-06-15

INLINE AUTOTRANSFUSION SYSTEM

Applicant Conmedcorp

K number K890171

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CAC 1989-05-22

AUTOTRANSFUSION DEVICE

Applicant Impra, Inc.

K number K892819

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CAC 1989-05-05

SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM-PROGRAMM

Applicant Shiley, Inc.

K number K884564

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CAC 1989-01-24

PLEUR-EVAC(R) A-7002--ADULT/PEDIATRIC DRAINAGE

Applicant Deknatel, Inc.

K number K884844

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CAC 1988-12-27

CELL SAVER HAEMOLITE B AUTO. BLOOD RECOVERY SYSTEM

Applicant Haemonetics Corp.

K number K883934

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CAC 1988-10-28

SOLCOTRANS ORTHO. DRAINAGE/REINFUSION SYSTEM

Applicant Solco Basle, Inc.

K number K883058

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CAC 1988-10-13

PLEUR-EVAC(R)-A-7020-INFANT CHEST DRAIN SYSTEM

Applicant Deknatel, Inc.

K number K883082

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CAC 1988-09-30

ATS BLOOD RECOVERY BAG

Applicant Atrium Medical Corp.

K number K883663

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CAC 1988-09-30

CBC/CONSTAVAC BLOOD CONSERVATION SYSTEM

Applicant Stryker Corp.

K number K881350

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CAC 1988-09-09

BIODYNAMICS AUTOTRANSFUSION RESERVOIR

Applicant Biodynamics Corp.

K number K881631

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CAC 1988-09-01

ARGYLE AUTOTRANSFUSION BAG

Applicant Sherwood Medical Co.

K number K882757

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CAC 1988-07-08

DIDECO-SHILEY FLUID COLLECTION BAG

Applicant Shiley, Inc.

K number K881692

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CAC 1988-06-27

DIDECO-SHILEY AUTOTRANS BT 795/AA

Applicant Shiley, Inc.

K number K881683

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CAC 1988-06-14

AUTO-VAC INTRAOPERATIVE AUTOTRANS. RESERVOIR #7904

Applicant Boehringer Laboratories

K number K881129

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CAC 1988-05-04

DIDECO-SHILEY FEED TUBE SUPPORT ARMS AND HOOK

Applicant Shiley, Inc.

K number K881421

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CAC 1988-03-21

PLEUR-EVAC--A-5002 CHEST DRAINAGE SYSTEM W/AUTO

Applicant Deknatel, Inc.

K number K880162

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CAC 1988-03-09

AUTOTRANSFUSION APPARATUS

Applicant Biodynamics Corp.

K number K873807

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CAC 1988-02-12

BIOSURGE MODEL OASYS-II

Applicant Biosurge, Inc.

K number K875023

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CAC 1987-10-09

DAVOL INTRAOPERATIVE AUTOTRANSFUSION KIT

Applicant C.R. Bard, Inc.

K number K872927

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CAC 1987-09-04

SOLCOTRANS CHEST DRAINAGE AUTOTRANSFUSION SYSTEM

Applicant Solco Basle, Inc.

K number K872590

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CAC 1987-08-05

SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM (REMOTE)

Applicant Shiley, Inc.

K number K872814

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CAC 1987-07-24

DIDECO-SHILEY BLOOD SEPARATION WASH BOWL

Applicant Shiley, Inc.

K number K872160

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CAC 1987-07-21

DIDECO-SHILEY BLOOD REINFUSION BAG

Applicant Shiley, Inc.

K number K872162

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CAC 1987-07-21

DIDECO-SHILEY WASTE COLLECTION BAG

Applicant Shiley, Inc.

K number K872158

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CAC 1987-06-22

THORA-DRAIN(R) ABT SYSTEM

Applicant Sherwood Medical Co.

K number K871624

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CAC 1987-06-22

PLEURA-GARD ATS

Applicant Conmedcorp

K number K871568

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CAC 1987-06-19

BT-795/ATS

Applicant Electromedics, Inc.

K number K871847

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CAC 1987-05-21

BIOSURGE MODEL OASYS

Applicant Biosurge, Inc.

K number K871258

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CAC 1987-03-16

ARGYLE SENTINEL SEAL AUTOTRANSFUSION SYSTEM

Applicant Sherwood Medical Co.

K number K864374

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CAC 1986-10-17

AUTO-VAC (TM) AUTOTRANSFUSION RESERV, MODEL 7900

Applicant Boehringer Laboratories

K number K862684

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CAC 1986-06-16

PHARMASEAL MEDI-VAC INTRA-OPER. AUTOTRANSFUS. KIT

Applicant American Pharmaseal Div. Ahsc

K number K861677

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CAC 1986-03-06

BT-795/P AUTOMATED AUTOTRANS

Applicant Electromedics, Inc.

K number K860306

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CAC 1985-12-27

EXU-BAG CSU-1200(DISPOS)CANISTER 602-2(NON-DISPOS

Applicant American Omni Medical, Inc.

K number K852178

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CAC 1985-11-19

PLEUR-EVAC II AUTOTRANSFUSION SYSTEM

Applicant Deknatel, Inc.

K number K854301

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CAC 1985-10-01

SOLCO BASLE INTRAOPERATIVE AUTOTTRNSFUS

Applicant Solco Basle, Inc.

K number K843821

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CAC 1985-09-18

BAYLOR RAPID AUTOTRANSFUSION SYSTEM

Applicant Cardio Systems, Inc.

K number K852736

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CAC 1985-09-03

CELL SAVER SUCTION SYSTEM

Applicant Haemonetics Corp.

K number K852425

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CAC 1985-05-23

PLEUR-EVAC AUTOTRANSFUSION SYSTEM -TENTATIVE

Applicant Pfizer, Inc.

K number K851024

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CAC 1984-10-04

GUIDELINES FOR PEDIATRIC ANESTHESIA

Applicant Critical Care Micro Computing

K number K842610

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CAC 1983-12-29

PLEURAL DRAINAGE SYS #PDS-100-4

Applicant American Bentley

K number K831849

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CAC 1983-08-24

INTRAOPERATIVE AUTOTRANSFUSION SYS

Applicant Thoratec Laboratories Corp.

K number K831557

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CAC 1983-05-02

BT 795/A AUTOTRANS

Applicant Electromedics, Inc.

K number K830735

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CAC 1981-10-23

AUTOTRANS BT795

Applicant Electromedics, Inc.

K number K812292

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CAC 1981-09-09

IBM 2991 BLOOD CELL PROCESSOR MOD. 1 & 2

Applicant Intl. Business Machines

K number K812355

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CAC 1981-06-09

SORENSON CATALOG #IFL-120S

Applicant Sorensen Research

K number K811228

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CAC 1981-01-08

RESERVOIR FOR AUTOLOGOUS BLOOD TRANSFUS.

Applicant Haemonetics Corp.

K number K802674

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CAC 1979-12-05

ACU-MED RED MISER HEMOTHORAX BLOOD COLL.

Applicant Acumed Instruments Corp.

K number K791891

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CAC 1978-10-26

MEDIASTINAL DRAINAGE TUBE SET MDT-36TC2

Applicant Sorensen Research

K number K781553

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CAC 1978-10-26

MEDIASTINAL DRAINAGE TUBE SET MDT-32TC2

Applicant Sorensen Research

K number K781552

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CAC 1978-10-26

TRAUMA DRAINAGE SET 72T-32TTC

Applicant Sorensen Research

K number K781551

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CAC 1978-10-26

TRAUMA DRAINAGE SET 72T-28TTC

Applicant Sorensen Research

K number K781550

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CAC 1978-01-03

RECEPTAL ATS MEDIASTINAL LINER

Applicant Sorensen Research

K number K772280

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CAC 1977-12-22

RECEPTAL ATS TRAUMA KGA1900L

Applicant Sorensen Research

K number K772196

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