Medical Device Manufacturer · US , Mchenry , IL

Haemonetics Corp.

28 submissions · 28 cleared · Since 1980
28
Total
28
Cleared
0
Denied

Haemonetics Corp. — FDA 510(k) Submissions

Haemonetics Corp. has submitted 28 FDA 510(k) premarket notifications since 1980, of which 28 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Apparatus, Autotransfusion, Container, Empty, For Collection & Processing Of Blood & Blood Components, Pump, Portable, Aspiration (manual Or Powered), Set, Administration, Intravascular, Pump, Infusion . Use the specialty filter in the sidebar to narrow results.

28 devices
1–25 of 28
ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM
K122262 · CAC Apparatus, Autotransfusion · Anesthesiology
Oct 2012 90d
CELL SAVER ELITE
K120586 · CAC Apparatus, Autotransfusion · Anesthesiology
May 2012 85d
HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM
K101907 · CAC Apparatus, Autotransfusion · Anesthesiology
Dec 2010 148d
SMARTSUCTION SOLO DEVICE
K062801 · BTA Pump, Portable,... · General & Plastic Surgery
Oct 2006 15d
HAEMONETICS 40U RBC FILTER BAG
K061103 · CAK Microfilter, Blood... · General Hospital
May 2006 27d
HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT)
K053000 · CAC Apparatus, Autotransfusion · Anesthesiology
Nov 2005 27d
SMARTSUCTION HARMONY DEVICE
K052626 · BTA Pump, Portable,... · General & Plastic Surgery
Oct 2005 12d
HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM
K043127 · CAC Apparatus, Autotransfusion · Anesthesiology
Jan 2005 53d
HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM
K014083 · CAC Apparatus, Autotransfusion · Anesthesiology
Jan 2002 28d
HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER HAEMOLITE 2 FAMILY OF AUTOLOGOUS BLOOD RECOVER
K993581 · CAC Apparatus, Autotransfusion · Anesthesiology
Nov 1999 27d
HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SET
K953681 · LKN Separator, Automated,... · Gastroenterology & Urology
Jun 1996 302d
AUTOFLO INTRA-OP SHED BLOOD AUTORTRANSFUSTION SYS
K944232 · CAC Apparatus, Autotransfusion · Anesthesiology
Jul 1995 322d
CELL SAVER 5 SYSTEM
K932890 · CAC Apparatus, Autotransfusion · Anesthesiology
Jan 1994 205d
HAEMONETICS CELL SAVER 4 PLUS
K904041 · CAC Apparatus, Autotransfusion · Anesthesiology
Nov 1990 70d
HAEMONETICS LN 200F COLLECTION RESERVOIR
K904474 · CAC Apparatus, Autotransfusion · Anesthesiology
Nov 1990 43d
ORTHOPEDIC WOUND DRAINAGE SET WITH TROCAR
K893394 · CAC Apparatus, Autotransfusion · Anesthesiology
Oct 1989 171d
CELL SAVER HAEMOLITE B AUTO. BLOOD RECOVERY SYSTEM
K883934 · CAC Apparatus, Autotransfusion · Anesthesiology
Dec 1988 103d
HAEMONETICS CELL SAVER MINI SAVER AUTO. BLOOD SYS.
K872895 · CAL Laryngoscope, Non-rigid · Anesthesiology
Jan 1988 172d
FLUID MANAGEMENT SYSTEM (MODIFIED)
K860969 · FRN Pump, Infusion · General Hospital
May 1986 56d
FLUID MANAGEMENT SYSTEM
K852645 · FRN Pump, Infusion · General Hospital
Dec 1985 171d
CELL SAVER SUCTION SYSTEM
K852425 · CAC Apparatus, Autotransfusion · Anesthesiology
Sep 1985 88d
HAEMONETICS 1000ML COMPONENT BAG
K811449 · KSR Container, Empty, For... · Hematology
Jul 1981 40d
HAEMONETICS 600 ML. COMPONENT BAG
K810711 · KSR Container, Empty, For... · Hematology
May 1981 52d
HAEMONETICS 1400 ML THERAPEUTIC BAG
K810313 · KSR Container, Empty, For... · Hematology
Mar 1981 54d
HAEMONETICS 170 Y INFUSION SET
K810365 · FPA Set, Administration,... · General Hospital
Mar 1981 47d
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