FDA 510(k) Applications for Medical Device:
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K992592 | A-MED SYSTEMS, INC. |
2491 BOATMAN AVE. | WEST SACRAMENTO | CA | 95691 |
| K013393 | A-MED SYSTEMS, INC. |
2491 BOATMAN AVE. | WEST SACRAMENTO | CA | 95691 |
| K020529 | A-MED SYSTEMS, INC. |
2491 BOATMAN AVE. | WEST SACRAMENTO | CA | 95691 |
| K083111 | ABIOMED, INC. |
22 CHERRY HILL DR. | DANVERS | MA | 01923 |
| K093801 | ABIOMED, INC. |
22 CHERRY HILL DR. | DANVERS | MA | 01923 |
| K110845 | ABIOMED, INC. |
22 CHERRY HILL DR. | DANVERS | MA | 01923 |
| K063723 | ABIOMED, INC. |
22 CHERRY HILL DR. | DANVERS | MA | 01923 |
| K952879 | BAXTER HEALTHCARE CORP. |
17511 ARMSTRONG AVE. | IRVINE | CA | 92713-9522 |
| K991783 | CARDIAC ASSIST, INC. |
240 ALPHA DR. | PITTSBURGH | PA | 15238 |
| K183623 | CardiacAssist Inc |
620 Alpha Drive | Pittsburgh | PA | 15238 |
| K110493 | CARDIACASSIST INC. |
240 ALPHA DRIVE | PITTSBURGH | PA | 15238 |
| K232132 | CardiacAssist, Inc. |
620 Alpha Drive | Pittsburgh | PA | 15238 |
| K012325 | CARDIOVENTION, INC. |
3045 STENDER WAY | SANTA CLARA | CA | 95054 |
| K011835 | COBE CARDIOVASCULAR, INC. |
14401 WEST 65TH WAY | ARVADA | CO | 80004 |
| K030462 | COBE CARDIOVASCULAR, INC. |
14401 WEST 65TH WAY | ARVADA | CO | 80004 |
| K032040 | DIDECO S.P.A. |
195 WEST ST. | WALTHAM | MA | 02451-1163 |
| K030154 | DIDECO S.P.A. |
195 WEST ST. | WALTHAM | MA | 02451-1163 |
| K050890 | DIDECO S.R.L. |
195 WEST ST. | WALTHAM | MA | 02451 |
| K031300 | GISH BIOMEDICAL, INC. |
11874 SOUTH EVELYN CIRCLE | HOUSTON | TX | 77071 |
| K972740 | HIMEX PRODUCTION CORP. |
MEDICAL TOWERS BLDG | HOUSTON | TX | 77030 |
| K983272 | INTERNATIONAL BIOPHYSICS CORP. |
4020 SOUTH INDUSTRIAL DR. | AUSTIN | TX | 78744 |
| K170029 | INTERNATIONAL BIOPHYSICS CORPORATION |
2101 E. ST. ELMO ROAD | AUSTIN | TX | 78744 |
| K193663 | International Biophysics Corporation |
2101 E. St. Elmo Road | Austin | TX | 78744 |
| K023132 | JOSTRA AG |
2828 N. CRESCENT RIDGE DR. | THE WOODLANDS | TX | 77381 |
| K991864 | JOSTRA MEDIZINTECHNIK AG |
2035 SUNSET LAKE RD. | NEWARK | DE | 19702 |
| K051209 | LEVITRONIX LLC. |
45 FIRST AVE. | WALTHAM | MA | 02451 |
| K020271 | LEVITRONIX LLC. |
85 FIRST AVE. | WALTHAM | MA | 02451 |
| K090051 | LEVITRONIX LLC. |
45 FIRST AVE. | WALTHAM | MA | 02451 |
| K103357 | LIFEBRIDGE MEDIZINTECHNIK AG |
1282 ROUND HILL RD. | BRYN MAWR | PA | 19010 |
| K111384 | LIFEBRIDGE MEDIZINTECHNIK AG |
P.O. BOX 2042 | FAIRFIELD | IA | 52556 |
| K083794 | MAQUET CARDIOPULMONARY AG |
HECHINGER STRASSE 38 | HIRRLINGEN | 72145 | |
| K133265 | MAQUET CARDIOPULMONARY AG |
45 BARBOUR POND DRIVE | WAYNE | NJ | 07470 |
| K080470 | MAQUET CARDIOPULMONARY AG |
HECHINGER STRASSE 38 | HIRRLINGEN | 72145 | |
| K061072 | MAQUET CARDIOPULMONARY AG |
HECHINGER STRASSE 38 | HIRRLINGEN | 72145 | |
| K090515 | MAQUET CARDIOPULMONARY AG |
HECHINGER STRASSE 38 | HIRRLINGEN | 72145 | |
| K973011 | MEDTRONIC BIO-MEDICUS, INC. |
9600 WEST 76TH ST. | EDEN PRAIRIE | MN | 55344 |
| K191077 | Medtronic Inc |
7611 Northland Drive | Minneapolis | MN | 55428 |
| K100631 | MEDTRONIC INC. |
7611 NORTHLAND DRIVE | MINNEAPOLIS | MN | 55428 |
| K111658 | MEDTRONIC INC. |
8200 CORAL SEA ST NE | MOUNDS VIEW | MN | 55112 |
| K132712 | MEDTRONIC INC. |
8200 Coral Sea Street NE | Mounds View | MN | 55112 |
| K111972 | MEDTRONIC INC. |
7611 NORTHLAND DRIVE | MINNEAPOLIS | MN | 55428 |
| K050109 | MEDTRONIC PERFUSION SYSTEMS |
7611 NORTHLAND DR. | MINNEAPOLIS | MN | 55038 |
| K111657 | MEDTRONIC, INC. |
8200 Coral Sea Street NE | Mounds View | MN | 55112 |
| K201068 | Medtronic, Inc. |
7611 Northland Drive | Minneapolis | MN | 55428 |
| K033270 | NOVOSCI CORP. |
2828 NORTH CRESCENT RIDGE DR. | THE WOODLANDS | TX | 77381-3902 |
| K073631 | ORQIS MEDICAL CORPORATION |
14 ORCHARD ROAD, SUITE 100 | LAKE FOREST | CA | 92630 |
| K202169 | Qura S.r.l |
Via di Mezzo, 23 | Mirandola | 41037 | |
| K220842 | Qura S.r.l. |
Via di Mezzo, 23 | Mirandola | 41037 | |
| K233091 | Qura S.r.l. |
Via di Mezzo, 23 | Mirandola | 41037 | |
| K201320 | Qura S.r.l. |
Via di Mezzo 23 | Mirandola | 41037 | |
| K192850 | Qura S.r.l. |
Via di Mezzo, 23 | Mirandola | 41037 | |
| K190650 | SORIN GROUP ITALIA S.R.L. |
Via Statale 12 Nord, 86 | Mirandola | 41037 | |
| K250326 | Spectrum Medical S.r.l. |
Via di Mezzo, 23 | Mirandola | 41037 | |
| K112229 | TERUMO CARDIOVASCULAR SYSTEMS |
6200 JACKSON RD | ANN ARBOR | MI | 48103 |
| K080774 | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K012209 | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K020998 | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K082321 | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K200091 | Terumo Cardiovascular Systems Corporation |
6200 Jackson Road | Ann Arbor | MI | 48103 |
| K962981 | TERUMO MEDICAL CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
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