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 | |
| K240190 | Medtronic |
8200 Coral Sea Street NE | Mounds View | MN | 55040 |
| 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 | |
| K250150 | Sorin Group Italia S.r.l. |
Via Statale 12 Nord, 86 | Mirandola (Modena) | 41037 | |
| K240908 | Spectrum Medical Ltd. |
Harrier 4, Meteor Business Park, 128 Cheltenham Road East | Gloucester | GL2 9QL | |
| 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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