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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