Product Code: CAC
FDA class 2
21 CFR 868.5830
Apparatus, Autotransfusion
Anesthesiology
The Apparatus, Autotransfusion is a device used to collect, filter, and reinfuse a patient's own blood lost during surgery, reducing the need for allogeneic blood transfusions and their associated risks. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is CAC, regulated under 21 CFR 868.5830 in the Anesthesiology specialty, reviewed by the Cardiovascular panel. This device is designated as life-sustaining or life-supporting.
510(k)s
195
FEI Numbers
54
Registration Numbers
54
Unique Applicants
78
Years Active
47
Basic Information
- Product Code
- CAC
- Device Class
- FDA class 2
- Regulation Number
- 868.5830
- Medical Specialty
- Anesthesiology
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✓
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 195 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K241236 | XTRA Collection sets; XTRA Sequestration set X | Aug 16, 2024 | Substantially Equivalent | Sorin Group Italia S.r.l. |
| K240426 | Aventus Clot Management System | May 14, 2024 | Substantially Equivalent | Inquis Medical |
| K240584 | XTRA Autotransfusion System (with XTRA Bowl sets) | Apr 29, 2024 | Substantially Equivalent | Sorin group Italia S.r.l. |
| K231782 | FlowSaver Blood Return System (80-101) | Jul 14, 2023 | Substantially Equivalent | Inari Medical, Inc. |
| K221483 | FlowSaver Blood Return System | Feb 17, 2023 | Substantially Equivalent | Inari Medical, Inc. |
| K221722 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) | Nov 15, 2022 | Substantially Equivalent | Haemonetics Corporation |
| K201305 | Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain | Sep 03, 2021 | Substantially Equivalent | Atrium Medical Corporation |
| K210862 | Hemafuse System | Jul 29, 2021 | Substantially Equivalent | Sisu Global Health |
| K210176 | FlowSaver Blood Filter | Jul 22, 2021 | Substantially Equivalent | Inari Medical |
| K210089 | CATSmart, Automated Blood Processing Autotransfusion System | Feb 11, 2021 | Substantially Equivalent | Fresenius Kabi AG |
| K193361 | ProCell Surgical Sponge-Blood Recovery Unit | Jun 01, 2020 | Substantially Equivalent | ProCell Surgical, Inc. |
| K192368 | CATSmart | Sep 27, 2019 | Substantially Equivalent | Fresenius Kabi AG |
| K180831 | CATSmart | Dec 10, 2018 | Substantially Equivalent | Fresenius Kabi AG |
| K181954 | autoLog IQ Autotransfusion System | Aug 22, 2018 | Substantially Equivalent | MEDTRONIC PERFUSION SYSTEMS |
| K162423 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System | Jan 03, 2017 | Substantially Equivalent | HAEMONETICS CORPORATION |
| K160735 | CATSmart | Sep 16, 2016 | Substantially Equivalent | FRESENIUS KABI AG |
| K160197 | Haemonetics Cell Saver Elite Autotransfusion System | May 24, 2016 | Substantially Equivalent | Haemonetics Corporation |
| K140205 | PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM | Oct 23, 2014 | Substantially Equivalent | Teleflex Medical, Inc. |
| K140197 | PLEUR-EVAC PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM | Oct 21, 2014 | Substantially Equivalent | Teleflex Medical, Inc. |
| K131553 | XTRA | Mar 21, 2014 | Substantially Equivalent | SORIN GROUP DEUTSCHLAND GMBH |
| K130043 | PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM | Feb 12, 2013 | Substantially Equivalent | Teleflex Medical, Inc. |
| K120953 | PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM | Dec 10, 2012 | Substantially Equivalent | TLELFLEX MEDICAL, INC. |
| K122262 | ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM | Oct 25, 2012 | Substantially Equivalent | HAEMONETICS CORP. |
| K120586 | CELL SAVER ELITE | May 22, 2012 | Substantially Equivalent | HAEMONETICS CORP. |
| K112245 | XTRA | Sep 06, 2011 | Substantially Equivalent | SORIN GROUP ITALIA S.R.L |
| K110782 | XVAC | Apr 07, 2011 | Substantially Equivalent | SORIN GROUP ITALIA S.R.L. |
| K101907 | HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM | Dec 03, 2010 | Substantially Equivalent | HAEMONETICS CORP. |
| K103202 | PREASSEMBLED SURGICAL WASH SET | Nov 23, 2010 | Substantially Equivalent | SORIN GROUP ITALIA S.R.L. |
| K101586 | XTRA AUTOTRANSFUSION SYSTEM | Oct 05, 2010 | Substantially Equivalent | SORIN GROUP ITALIA S.R.L. |
| K093535 | AUTOLOG AUTOTRANSFUSION SYSTEM | Mar 22, 2010 | Substantially Equivalent | MEDTRONIC INC. |
| K082923 | PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C | Oct 24, 2008 | Substantially Equivalent | LIFE-TECH, INC. |
| K060482 | CYTORI CELUTION CELL CONCENTRATION DEVICE | Sep 28, 2006 | Substantially Equivalent | CYTORI THERAPEUTICS, INC. |
| K053000 | HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT) | Nov 21, 2005 | Substantially Equivalent | HAEMONETICS CORP. |
| K043127 | HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM | Jan 04, 2005 | Substantially Equivalent | HAEMONETICS CORP. |
| K043140 | EXPRESS AND OASIS CHEST DRAIN | Dec 08, 2004 | Substantially Equivalent | ATRIUM MEDICAL CORP. |
| K041525 | HEMOVAC BLOOD REINFUSION SYSTEM | Oct 14, 2004 | Substantially Equivalent | ZIMMER, INC. |
| K031554 | S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM | Jul 25, 2003 | Substantially Equivalent | GENZYME BIOSURGERY |
| K022167 | PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM | Mar 07, 2003 | Substantially Equivalent | PALL CORP. |
| K024097 | SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14 | Feb 14, 2003 | Substantially Equivalent | SUMMIT MEDICAL LTD. |
| K022489 | SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514 | Oct 09, 2002 | Substantially Equivalent | SUMMIT MEDICAL LTD. |
| K020647 | DIDECO ELECTA | Sep 05, 2002 | Substantially Equivalent | DIDECO S.P.A. |
| K022348 | ACCESS CONCENTRATION SYSTEM, MODEL ACC-100, ACCESS DISPOSABLE SET, MODEL ADS-2000 | Aug 15, 2002 | Substantially Equivalent | INTERPORE CROSS INTL. |
| K012406 | ACCESS SEQUESTRATION SYSTEM | Mar 26, 2002 | Substantially Equivalent | INTERPORE CROSS INTL. |
| K014187 | AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM | Feb 06, 2002 | Substantially Equivalent | BOEHRINGER LABORATORIES |
| K014083 | HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM | Jan 08, 2002 | Substantially Equivalent | HAEMONETICS CORP. |
| K012178 | FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW | Jul 23, 2001 | Substantially Equivalent | FRESENIUS HEMOTECHNOLOGY, INC. |
| K993581 | HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER HAEMOLITE 2 FAMILY OF AUTOLOGOUS BLOOD RECOVER | Nov 18, 1999 | Substantially Equivalent | HAEMONETICS CORP. |
| K992723 | ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM | Oct 18, 1999 | Substantially Equivalent | TRANSFUSION TECHNOLOGIES CORP. |
| K991986 | COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH THE CRIT-LINE HEMATOCRIT SAMPLING SYSTEM OPTION | Sep 09, 1999 | Substantially Equivalent | COBE CARDIOVASCULAR, INC. |
| K983022 | SMARTCELL PROCESSING SYSTEM | Apr 02, 1999 | Substantially Equivalent | HARVEST TECHNOLOGIES, LLC. |
| K982660 | ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM | Mar 30, 1999 | Substantially Equivalent | TRANSFUSION TECHNOLOGIES CORP. |
| K984233 | C.A.T.S AUTOTRANSFUSION ACCESSORIES, MODELS ATS SUCTION LINE, ATY Y-ADAPTER, AND ATO OXYGENATOR LINE | Feb 01, 1999 | Substantially Equivalent | FRESENIUS HEMOTECHNOLOGY, INC. |
| K982712 | RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250 | Dec 18, 1998 | Substantially Equivalent | GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) |
| K982650 | AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS) | Dec 16, 1998 | Substantially Equivalent | DIDECO S.P.A. |
| K982241 | BETATRANS INTRAOP I AND II MODEL NUMBERS DS100X AND DS10XX | Nov 30, 1998 | Substantially Equivalent | DUXBURY SCIENTIFIC INC. |
| K982755 | MODIFICATION OF AUTOTRANSFUSION APPARATUS (AUTOLOG) | Aug 20, 1998 | Substantially Equivalent | MEDTRONIC BLOOD MANAGEMENT |
| K972894 | AUTOTRANSFUSION APPARTUS (AUTOLOG) | Apr 27, 1998 | Substantially Equivalent | MEDTRONIC BLOOD MANAGEMENT |
| K974897 | COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET | Mar 31, 1998 | Substantially Equivalent | COBE CARDIOVASCULAR, INC. |
| K963759 | DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS | Feb 20, 1998 | Substantially Equivalent | SORIN BIOMEDICAL, INC. |
| K963758 | CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE | Feb 20, 1998 | Substantially Equivalent | SORIN BIOMEDICAL, INC. |
| K970714 | STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII) | Dec 16, 1997 | Substantially Equivalent | STRYKER INSTRUMENTS |
| K970857 | ARGYLE AQUA-SEAL ALL PURPOSE AUTOTRANSFUSION CHEST DRAINAGE UNIT AND OPTIONAL ARGYLE AQUA-SEAL EVACUATING AUTOTRANSFUSIO | Nov 05, 1997 | Substantially Equivalent | DAVIS & GECK, INC. |
| K973627 | STANDARD VOLUME PROCESSING SET FOR THE COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM | Nov 03, 1997 | Substantially Equivalent | COBE CARDIOVASCULAR, INC. |
| K973378 | C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61 | Nov 03, 1997 | Substantially Equivalent | FRESENIUS USA, INC. |
| K971274 | C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM, AT1 AUTOTRANSFUSION SET, PSQ SET | Jun 13, 1997 | Substantially Equivalent | FRESENIUS AG |
| K963850 | PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM | Apr 22, 1997 | Substantially Equivalent | DEKNATEL, INC. |
| K962475 | ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM | Feb 20, 1997 | Substantially Equivalent | TRANSFUSION TECHNOLOGIES CORP. |
| K962689 | COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH MODIFIED PLASMA RECOVERY PROGRAM (PRP) | Jan 28, 1997 | Substantially Equivalent | COBE CARDIOVASCULAR, INC. |
| K964070 | DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAG | Dec 31, 1996 | Substantially Equivalent | DEKNATEL, INC. |
| K960734 | HAEMOCELL SYSTEM 350 OR S350 | Dec 10, 1996 | Substantially Equivalent | HAEMOCELL PLC |
| K963098 | PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100) | Nov 08, 1996 | Substantially Equivalent | DEKNATEL, INC. |
| K960006 | C.A.T.S. CONTINUOUS AUTOTRANSFUSION SYSTEM | Jul 31, 1996 | Substantially Equivalent | FRESENIUS AG |
| K955010 | AUTOVAC BP SYSTE, 2000 SERIES | Jun 20, 1996 | Substantially Equivalent | BOEHRINGER LABORATORIES |
| K942844 | LEVEL 1 BLOOD STREAM RECOVERY SYSTEM | Apr 26, 1996 | Substantially Equivalent | LEVEL 1 TECHNOLOGIES, INC. |
| K951592 | BETATRANS I AND II | Mar 04, 1996 | Substantially Equivalent | DUXBURY SCIENTIFIC INC. |
| K953118 | CARACELL | Feb 23, 1996 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K952224 | STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII) | Nov 17, 1995 | Substantially Equivalent | STRYKER INSTRUMENTS |
| K945775 | BOEHRINGER AUTOVAC(R) 7900 SERIES | Oct 19, 1995 | Substantially Equivalent | BOEHRINGER LABORATORIES |
| K944232 | AUTOFLO INTRA-OP SHED BLOOD AUTORTRANSFUSTION SYS | Jul 20, 1995 | Substantially Equivalent | HAEMONETICS CORP. |
| K942791 | ARGYLE AQUA-SEAL CONTINUOUS AUTOTRANSFUSION CHEST DRAINAGE UNIT | May 10, 1995 | Substantially Equivalent | SHERWOOD MEDICAL CO. |
| K936220 | DIDECO VACUUM PUMP | Jan 27, 1995 | Substantially Equivalent | DIDECO |
| K940519 | DIDECO COMPACT-A AUTOTRANSFUSION SYSTEM | Jan 19, 1995 | Substantially Equivalent | DIDECO |
| K931899 | DAVOL ATS | Nov 15, 1994 | Substantially Equivalent | DAVOL, INC. |
| K926338 | PLEUR-EVAC CARDIOTOMY RESERVOIR # CR-9400 & 9400F | Jul 26, 1994 | Substantially Equivalent | DEKNATEL, INC. |
| K932093 | AUTOVAC CLOSED WOUND AUTOTRANSFUSION SYSTEM,7920 S | Jul 06, 1994 | Substantially Equivalent | BOEHRINGER LABORATORIES |
| K933960 | PLASMA RECOVERY PROGRAM FOR THE COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM | Jun 10, 1994 | Substantially Equivalent | COBE CARDIOVASCULAR, INC. |
| K940678 | AUTOTRANSFUSION SUCTION RESERVOIR WITH FILTER | Apr 15, 1994 | Substantially Equivalent | BAXTER HEALTHCARE CORP. |
| K932890 | CELL SAVER 5 SYSTEM | Jan 05, 1994 | Substantially Equivalent | HAEMONETICS CORP. |
| K933625 | BRAT 2 AUTOLOGUS BLOOD SALVAGE SYSTEM | Dec 29, 1993 | Substantially Equivalent | COBE CARDIOVASCULAR, INC. |
| K931552 | DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT | Oct 08, 1993 | Substantially Equivalent | DAVOL, INC. |
| K931106 | BIOSURGE(TM) SYNCHRONOUS AUTOTRANS PROCEDURE KIT | Oct 06, 1993 | Substantially Equivalent | DEKNATEL, INC. |
| K925827 | IMPRAFLO(TM) POST OPERATIVE/DRAIN/REINFUS KIT/CANI | Jul 29, 1993 | Substantially Equivalent | IMPRA, INC. |
| K920618 | AUTOTRANSFUSION SUCTION SET | Mar 12, 1993 | Substantially Equivalent | LIFESTREAM INT'L, INC. |
| K913247 | SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM | Feb 25, 1993 | Substantially Equivalent | SOLCO BASLE, INC. |
| K913177 | SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM | Feb 25, 1993 | Substantially Equivalent | SOLCO BASLE, INC. |
| K915130 | MAT MEMBRANE AUTOTRANSFUSION SYSTEM | Feb 22, 1993 | Substantially Equivalent | ESTRACORPOREAL, INC. |
| K924894 | AUTOVAC 7900 SERIES | Feb 05, 1993 | Substantially Equivalent | BOEHRINGER LABORATORIES |
| K920273 | HEMOVAC AUTOTRANSFUSION SYSTEM | Jan 28, 1993 | Substantially Equivalent | ZIMMER PATIENT CARE DIVISION |
| K914119 | DAVOL ORTHOPAEDIC AUTOTRANSFUSION SYSTEM | Dec 03, 1992 | Substantially Equivalent | DAVOL, INC. |
| K923016 | AUTOLOGOUS BLOOD COLLECTION SET | Nov 23, 1992 | Substantially Equivalent | ADVANCED HAEMOTECHNOLOGIES |
| K914053 | SYSTEM 350 | Sep 25, 1992 | Substantially Equivalent | STRYKER CORP. |
| K913181 | AUTOLOGOUS BLOOD PROCESSING SYSTEM | May 20, 1992 | Substantially Equivalent | LIFESTREAM INT'L, INC. |
| K913773 | COBE BRAT SYSTEMS WITHOUT REINFUSION PROTECTION | Jan 27, 1992 | Substantially Equivalent | COBE CARDIOVASCULAR, INC. |
| K912956 | ATRIUM DUAL ATS WATER SEAL CHEST DRAIN UNIT | Nov 29, 1991 | Substantially Equivalent | ATRIUM MEDICAL CORP. |
| K912610 | MINI-OP ATS BLOOD RECOVERY BAG, MODEL 2955 | Nov 29, 1991 | Substantially Equivalent | ATRIUM MEDICAL CORP. |
| K912609 | MINI-OP ATS BLOOD RECOVERY BAG, MOEL 2950 | Nov 29, 1991 | Substantially Equivalent | ATRIUM MEDICAL CORP. |
| K910991 | SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM | Nov 27, 1991 | Substantially Equivalent | SHILEY, INC. |
| K913684 | DAVOL POST-OP AUTOTRANSFUSION SYSTEM | Nov 15, 1991 | Substantially Equivalent | DAVOL, INC. |
| K912019 | ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEM | Oct 08, 1991 | Substantially Equivalent | GISH BIOMEDICAL, INC. |
| K904164 | AUTOVAC (R) AUTOTRANSFUSION SYSTEM, 7900 MODIFIED | Sep 06, 1991 | Substantially Equivalent | BOEHRINGER LABORATORIES |
| K911656 | PLEUR-EVAC PLUS CONTIN. REINFUS. & AUTOINFUS. SYST | Aug 13, 1991 | Substantially Equivalent | PFIZER HOSPITAL PRODUCTS GROUP, INC. |
| K910238 | PORTABLE AUTO TRANSFUSION SYSTEM 500 | Jun 19, 1991 | Substantially Equivalent | ELECTROMEDICS, INC. |
| K910211 | ORTH-EVAC(TM) SUCTION HAND BULB MODEL NO. 01-150 | Apr 03, 1991 | Substantially Equivalent | DEKNATEL, INC. |
| K904888 | AUTOWAND(TM) 7XXX SERIES, MODIFICATION | Jan 16, 1991 | Substantially Equivalent | BOEHRINGER LABORATORIES |
| K904794 | IN-LINE ATS BLOOD RECOVERY BAG | Jan 08, 1991 | Substantially Equivalent | ATRIUM MEDICAL CORP. |
| K904515 | IMPRAFLO 3500 SERIES | Dec 04, 1990 | Substantially Equivalent | IMPRA, INC. |
| K904474 | HAEMONETICS LN 200F COLLECTION RESERVOIR | Nov 13, 1990 | Substantially Equivalent | HAEMONETICS CORP. |
| K904041 | HAEMONETICS CELL SAVER 4 PLUS | Nov 13, 1990 | Substantially Equivalent | HAEMONETICS CORP. |
| K901401 | DAVOL AUTOTRANSFUSION BLOOD PROCESSING SYSTEM | Oct 23, 1990 | Substantially Equivalent | DAVOL, INC. |
| K903392 | ELECTROMEDICS BT422-120 AND BT422-40 | Sep 06, 1990 | Substantially Equivalent | ELECTROMEDICS, INC. |
| K900483 | VARIDYNE AT POSTOPERATIVE ORTHOPEDIC AUTOTRANSFU. | Aug 29, 1990 | Substantially Equivalent | BAXTER HEALTHCARE CORP. |
| K902713 | ACCESS. KIT FOR THE BIOSURGE SYNCHRONOUS AUTOTRANS | Jul 25, 1990 | Substantially Equivalent | DIEMOLDING CORP. |
| K902059 | AUTOWAND(TM) 7XXX SERIES | Jul 24, 1990 | Substantially Equivalent | BOEHRINGER LABORATORIES |
| K902759 | COBE CLOSED WOUND DRAINAGE KIT | Jul 18, 1990 | Substantially Equivalent | COBE LABORATORIES, INC. |
| K901232 | IMPRAFLO AUTOTRANSFUSION DEVICE | Jul 18, 1990 | Substantially Equivalent | IMPRA, INC. |
| K902671 | COBE AUTOLOGOUS BLOOD SALVAGE RESERV W/W/O FILTER | Jul 17, 1990 | Substantially Equivalent | COBE LABORATORIES, INC. |
| K900325 | ORTH-EVAC TM | Jul 03, 1990 | Substantially Equivalent | DEKNATEL, INC. |
| K901138 | AUTOVAC(R) AUTOTRANSFUSION SYSTEM, 7900 SERIES | Jun 18, 1990 | Substantially Equivalent | BOEHRINGER LABORATORIES |
| K893218 | AP900/PRP MODULE AND ACCESSORIES, MODIFICATION | Jun 12, 1990 | Substantially Equivalent | ELECTROMEDICS, INC. |
| K900299 | ATS Y ADAPTER CODE #2452 | May 01, 1990 | Substantially Equivalent | ARTIUM MEDICAL CORP. |
| K896858 | SOLCOTRANS INTRAOPERATIVE AUTOTRANSFUSION SYSTEM | Apr 05, 1990 | Substantially Equivalent | SOLCO BASLE, INC. |
| K896857 | SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM | Apr 05, 1990 | Substantially Equivalent | SOLCO BASLE, INC. |
| K897127 | ATRIUM 2052 CHEST DRAIN, DUAL COLLECTION BLOOD | Mar 13, 1990 | Substantially Equivalent | ATRIUM MEDICAL CORP. |
| K897126 | ATRIUM 2050 CHEST DRAIN BLOOD RECOVERY SYSTEM | Mar 13, 1990 | Substantially Equivalent | ATRIUM MEDICAL CORP. |
| K895297 | AUTOTRANSFUSION RESERVIOR MODEL 7900 MODIFICATION | Mar 13, 1990 | Substantially Equivalent | BOEHRINGER LABORATORIES |
| K892443 | BLOOD RECOVERY/AUTOTRANSFUSION RESERVOIR ATR-2900 | Nov 08, 1989 | Substantially Equivalent | GISH BIOMEDICAL, INC. |
| K894668 | MODIFIED SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM | Oct 20, 1989 | Substantially Equivalent | SHILEY, INC. |
| K893394 | ORTHOPEDIC WOUND DRAINAGE SET WITH TROCAR | Oct 19, 1989 | Substantially Equivalent | HAEMONETICS CORP. |
| K894294 | DIDECO-SHILEY UNIVERSAL Y | Aug 15, 1989 | Substantially Equivalent | SHILEY, INC. |
| K893578 | PHARMASEAL MEDI-VAC STERILE POST-OP AUTOTRANS. SYS | Aug 01, 1989 | Substantially Equivalent | BAXTER HEALTHCARE CORP. |
| K893402 | COMPACT 2052(TM) DUAL COLLECTION BLOOD RECOVERY | Jun 23, 1989 | Substantially Equivalent | ATRIUM MEDICAL CORP. |
| K892857 | HARVESTING TUBE | Jun 15, 1989 | Substantially Equivalent | CONMED CORP. |
| K890171 | INLINE AUTOTRANSFUSION SYSTEM | Jun 15, 1989 | Substantially Equivalent | CONMED CORP. |
| K892819 | AUTOTRANSFUSION DEVICE | May 22, 1989 | Substantially Equivalent | IMPRA, INC. |
| K884564 | SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM-PROGRAMM | May 05, 1989 | Substantially Equivalent | SHILEY, INC. |
| K884844 | PLEUR-EVAC(R) A-7002--ADULT/PEDIATRIC DRAINAGE | Jan 24, 1989 | Substantially Equivalent | DEKNATEL, INC. |
| K883934 | CELL SAVER HAEMOLITE B AUTO. BLOOD RECOVERY SYSTEM | Dec 27, 1988 | Substantially Equivalent | HAEMONETICS CORP. |
| K883058 | SOLCOTRANS ORTHO. DRAINAGE/REINFUSION SYSTEM | Oct 28, 1988 | Substantially Equivalent | SOLCO BASLE, INC. |
| K883082 | PLEUR-EVAC(R)-A-7020-INFANT CHEST DRAIN SYSTEM | Oct 13, 1988 | Substantially Equivalent | DEKNATEL, INC. |
| K883663 | ATS BLOOD RECOVERY BAG | Sep 30, 1988 | Substantially Equivalent | ATRIUM MEDICAL CORP. |
| K881350 | CBC/CONSTAVAC BLOOD CONSERVATION SYSTEM | Sep 30, 1988 | Substantially Equivalent | STRYKER CORP. |
| K881631 | BIODYNAMICS AUTOTRANSFUSION RESERVOIR | Sep 09, 1988 | Substantially Equivalent | BIODYNAMICS CORP. |
| K882757 | ARGYLE AUTOTRANSFUSION BAG | Sep 01, 1988 | Substantially Equivalent | SHERWOOD MEDICAL CO. |
| K881692 | DIDECO-SHILEY FLUID COLLECTION BAG | Jul 08, 1988 | Substantially Equivalent | SHILEY, INC. |
| K881683 | DIDECO-SHILEY AUTOTRANS BT 795/AA | Jun 27, 1988 | Substantially Equivalent | SHILEY, INC. |
| K881129 | AUTO-VAC INTRAOPERATIVE AUTOTRANS. RESERVOIR #7904 | Jun 14, 1988 | Substantially Equivalent | BOEHRINGER LABORATORIES |
| K881421 | DIDECO-SHILEY FEED TUBE SUPPORT ARMS AND HOOK | May 04, 1988 | Substantially Equivalent | SHILEY, INC. |
| K880162 | PLEUR-EVAC--A-5002 CHEST DRAINAGE SYSTEM W/AUTO | Mar 21, 1988 | Substantially Equivalent | DEKNATEL, INC. |
| K873807 | AUTOTRANSFUSION APPARATUS | Mar 09, 1988 | Substantially Equivalent | BIODYNAMICS CORP. |
| K875023 | BIOSURGE MODEL OASYS-II | Feb 12, 1988 | Substantially Equivalent | BIOSURGE, INC. |
| K872927 | DAVOL INTRAOPERATIVE AUTOTRANSFUSION KIT | Oct 09, 1987 | Substantially Equivalent | C.R. BARD, INC. |
| K872590 | SOLCOTRANS CHEST DRAINAGE AUTOTRANSFUSION SYSTEM | Sep 04, 1987 | Substantially Equivalent | SOLCO BASLE, INC. |
| K872814 | SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM (REMOTE) | Aug 05, 1987 | Substantially Equivalent | SHILEY, INC. |
| K872160 | DIDECO-SHILEY BLOOD SEPARATION WASH BOWL | Jul 24, 1987 | Substantially Equivalent | SHILEY, INC. |
| K872162 | DIDECO-SHILEY BLOOD REINFUSION BAG | Jul 21, 1987 | Substantially Equivalent | SHILEY, INC. |
| K872158 | DIDECO-SHILEY WASTE COLLECTION BAG | Jul 21, 1987 | Substantially Equivalent | SHILEY, INC. |
| K871624 | THORA-DRAIN(R) ABT SYSTEM | Jun 22, 1987 | Substantially Equivalent | SHERWOOD MEDICAL CO. |
| K871568 | PLEURA-GARD ATS | Jun 22, 1987 | Substantially Equivalent | CONMED CORP. |
| K871847 | BT-795/ATS | Jun 19, 1987 | Substantially Equivalent | ELECTROMEDICS, INC. |
| K871258 | BIOSURGE MODEL OASYS | May 21, 1987 | Substantially Equivalent | BIOSURGE, INC. |
| K864374 | ARGYLE SENTINEL SEAL AUTOTRANSFUSION SYSTEM | Mar 16, 1987 | Substantially Equivalent | SHERWOOD MEDICAL CO. |
| K862684 | AUTO-VAC (TM) AUTOTRANSFUSION RESERV, MODEL 7900 | Oct 17, 1986 | Substantially Equivalent | BOEHRINGER LABORATORIES |
| K861677 | PHARMASEAL MEDI-VAC INTRA-OPER. AUTOTRANSFUS. KIT | Jun 16, 1986 | Substantially Equivalent | AMERICAN PHARMASEAL DIV. AHSC |
| K860306 | BT-795/P AUTOMATED AUTOTRANS | Mar 06, 1986 | Substantially Equivalent | ELECTROMEDICS, INC. |
| K852178 | EXU-BAG CSU-1200(DISPOS)CANISTER 602-2(NON-DISPOS | Dec 27, 1985 | Substantially Equivalent | AMERICAN OMNI MEDICAL, INC. |
| K854301 | PLEUR-EVAC II AUTOTRANSFUSION SYSTEM | Nov 19, 1985 | Substantially Equivalent | DEKNATEL, INC. |
| K843821 | SOLCO BASLE INTRAOPERATIVE AUTOTTRNSFUS | Oct 01, 1985 | Substantially Equivalent | SOLCO BASLE, INC. |
| K852736 | BAYLOR RAPID AUTOTRANSFUSION SYSTEM | Sep 18, 1985 | Substantially Equivalent | CARDIO SYSTEMS, INC. |
| K852425 | CELL SAVER SUCTION SYSTEM | Sep 03, 1985 | Substantially Equivalent | HAEMONETICS CORP. |
| K851024 | PLEUR-EVAC AUTOTRANSFUSION SYSTEM -TENTATIVE | May 23, 1985 | Substantially Equivalent | PFIZER, INC. |
| K842610 | GUIDELINES FOR PEDIATRIC ANESTHESIA | Oct 04, 1984 | Substantially Equivalent | CRITICAL CARE MICRO COMPUTING |
| K831849 | PLEURAL DRAINAGE SYS #PDS-100-4 | Dec 29, 1983 | Substantially Equivalent | AMERICAN BENTLEY |
| K831557 | INTRAOPERATIVE AUTOTRANSFUSION SYS | Aug 24, 1983 | Substantially Equivalent | THORATEC LABORATORIES CORP. |
| K830735 | BT 795/A AUTOTRANS | May 02, 1983 | Substantially Equivalent | ELECTROMEDICS, INC. |
| K812292 | AUTOTRANS BT795 | Oct 23, 1981 | Substantially Equivalent | ELECTROMEDICS, INC. |
| K812355 | IBM 2991 BLOOD CELL PROCESSOR MOD. 1 & 2 | Sep 09, 1981 | Substantially Equivalent | INTL. BUSINESS MACHINES |
| K811228 | SORENSON CATALOG #IFL-120S | Jun 09, 1981 | Substantially Equivalent | SORENSEN RESEARCH |
| K802674 | RESERVOIR FOR AUTOLOGOUS BLOOD TRANSFUS. | Jan 08, 1981 | Substantially Equivalent | HAEMONETICS CORP. |
| K791891 | ACU-MED RED MISER HEMOTHORAX BLOOD COLL. | Dec 05, 1979 | Substantially Equivalent | ACUMED INSTRUMENTS CORP. |
| K781553 | MEDIASTINAL DRAINAGE TUBE SET MDT-36TC2 | Oct 26, 1978 | Substantially Equivalent | SORENSEN RESEARCH |
| K781552 | MEDIASTINAL DRAINAGE TUBE SET MDT-32TC2 | Oct 26, 1978 | Substantially Equivalent | SORENSEN RESEARCH |
| K781551 | TRAUMA DRAINAGE SET 72T-32TTC | Oct 26, 1978 | Substantially Equivalent | SORENSEN RESEARCH |
| K781550 | TRAUMA DRAINAGE SET 72T-28TTC | Oct 26, 1978 | Substantially Equivalent | SORENSEN RESEARCH |
| K772280 | RECEPTAL ATS MEDIASTINAL LINER | Jan 03, 1978 | Substantially Equivalent | SORENSEN RESEARCH |
| K772196 | RECEPTAL ATS TRAUMA KGA1900L | Dec 22, 1977 | Substantially Equivalent | SORENSEN RESEARCH |
FEI Numbers
This FDA classification entry is associated with 54 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 54 registration numbers. Click on an entry to view related FDA registrations.