FDA 510(k) Applications for Medical Device:
Heat-Exchanger, Cardiopulmonary Bypass

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K032068 CARDIOVENTION, INC. 3045 STENDER WAY
SANTA CLARA CA 95054
K012898 COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY
ARVADA CO 80004
K021830 COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY
ARVADA CO 80004
K081838 GISH BIOMEDICAL, INC. 22942 ARROYO VISTA
RANCHO SANTA MARGARITA CA 92688
K040355 GISH BIOMEDICAL, INC. 11874 SOUTH EVELYN CIRCLE
HOUSTON TX 77071
K020106 GISH BIOMEDICAL, INC. 11874 SOUTH EVELYN CIRCLE
HOUSTON TX 77071
K964571 LIFESTREAM INT'L, INC. 49 PLAIN ST.
NORTH ATTLEBORO MA 02760
K090555 MAQUET CARDIOPULMONARY AG HECHINGER STRASSE 38
HIRRLINGEN 72145
K072583 MAQUET CARDIOPULMONARY AG HECHINGER STRASSE 38
HIRRLINGEN 72145
K973475 MEDTRONIC VASCULAR 4633 E. LA PALMA AVE.
ANAHEIM CA 92807
K003724 MEDTRONIC VASCULAR 7600 NORTHLAND DR.
MINNEAPOLIS MN 55428
K162774 Medtronic, Inc. 8200 Coral Sea Street NE
Mounds View MN 55112
K162958 Medtronic, Inc. 7611 Northland Drive North
Minneapolis MN 55428
K991137 MINNTECH CORP. 14605 28TH AVE. NORTH
MINNEAPOLIS MN 55447
K000977 OLSON MEDICAL SALES, INC. 125 BLUE BALL RD.
ELKTON MD 21921
K223879 Quara S.r.l. Via di Mezzo, 23
Mirandola 41037
K200438 Quest Medical, Inc. One Allentown Parkway
Allen TX 75002
K201984 Quest Medical, Inc. One Allentown Parkway
Allen TX 75002
K041979 QUEST MEDICAL, INC. ONE ALLENTOWN PKWY.
ALLEN TX 75002
K173716 Quest Medical, Inc. One Allentown Parkway
Allen TX 75002-4211
K953838 QUEST MEDICAL, INC. ONE ALLENTOWN PKWY.
ALLEN TX 75002
K220110 Qura S.r.l. Via di Mezzo, 23
Mirandola 41037
K212688 Qura S.r.l. Via di Mezzo, 23
Mirandola 41037
K962320 STOECKERT INSTRUMENTE 49 PLAIN ST.
NORTH ATTLEBORO MA 02760
K982467 TERUMO MEDICAL CORP. 125 BLUE BALL RD.
ELKTON MD 21921




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