FDA 510(k) Applications for Medical Device:
Reservoir, Blood, Cardiopulmonary Bypass
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K072697 | 3T MEDICAL SYSTEMS, LLC |
12553 S. WAMBLEE VALLEY ROAD | CONIFER | CO | 80433 |
| K971105 | AVECOR CARDIOVASCULAR, INC. |
7611 NORTHLAND DR. | MINNEAPOLIS | MN | 55428 |
| K974155 | BAXTER HEALTHCARE CORP. |
17221 RED HILL AVE. | IRVINE | CA | 92614 |
| K981628 | C.R. BARD, INC. |
25 COMPUTER DR. | HAVERHILL | MA | 01832 |
| K971013 | CHASE MEDICAL, INC. |
1876 FIRMAN DR. | RICHARDSON | TX | 75081 |
| K981284 | CIRCULATORY TECHNOLOGY, INC. |
21 SINGWORTH ST. | OYSTER BAY | NY | 11771 |
| K140321 | CIRCULATORY TECHNOLOGY, INC. |
21 SINGWORTH ST. | OYSTER BAY | NY | 11771 |
| K012942 | CIRCULATORY TECHNOLOGY, INC. |
21 SINGWORTH ST. | OYSTER BAY | NY | 11771 |
| K001822 | CIRCULATORY TECHNOLOGY, INC. |
21 SINGWORTH ST. | OYSTER BAY | NY | 11771 |
| K980786 | COBE CARDIOVASCULAR, INC. |
14401 WEST 65TH WAY | ARVADA | CO | 80004 |
| K994389 | COBE CARDIOVASCULAR, INC. |
14401 WEST 65TH WAY | ARVADA | CO | 80004 |
| K971669 | COBE CARDIOVASCULAR, INC. |
14401 WEST 65TH WAY | ARVADA | CO | 80004 |
| K984456 | COBE CARDIOVASCULAR, INC. |
14401 WEST 65TH WAY | ARVADA | CO | 80004 |
| K993001 | COBE CARDIOVASCULAR, INC. |
14401 WEST 65TH WAY | ARVADA | CO | 80004 |
| K990239 | COBE CARDIOVASCULAR, INC. |
14401 WEST 65TH WAY | ARVADA | CO | 80004 |
| K050111 | COBE CARDIOVASCULAR, INC. |
14401 WEST 65TH WAY | ARVADA | CO | 80004-3599 |
| K033641 | COBE CARDIOVASCULAR, INC. |
14401 WEST 65TH WAY | ARVADA | CO | 80004 |
| K992599 | DIDECO S.P.A. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K001602 | DIDECO S.P.A. |
195 WEST ST. | WALTHAM | MA | 02451-1163 |
| K033714 | DIDECO S.P.A. |
195 WEST ST. | WALTHAM | MA | 02451-1163 |
| K984586 | FRESENIUS HEMOTECHNOLOGY, INC. |
110 MASON CIRCLE SUITE A | CONCORD | CA | 94520-1238 |
| K051606 | GISH BIOMEDICAL, INC. |
11874 SOUTH EVELYN CIRCLE | HOUSTON | TX | 77071 |
| K964973 | GISH BIOMEDICAL, INC. |
2681 KELVIN AVE. | IRVINE | CA | 92614-5821 |
| K030726 | GISH BIOMEDICAL, INC. |
11874 SOUTH EVELYN CIRCLE | HOUSTON | TX | 77071 |
| K081947 | GISH BIOMEDICAL, INC. |
11874 SOUTH EVELYN CIRCLE | HOUSTON | TX | 77071 |
| K082082 | GISH BIOMEDICAL, INC. |
22942 ARROYO VISTA | RANCHO SANTA MARGARITA | CA | 92688 |
| K091062 | GISH BIOMEDICAL, INC. |
22942 ARROYO VISTA | RANCHO SANTA MARGARITA | CA | 92688 |
| K083131 | GISH BIOMEDICAL, INC. |
22942 ARROYO VISTA | RANCHO SANTA MARGARITA | CA | 92688 |
| K955046 | GISH BIOMEDICAL, INC. |
2681 KELVIN AVE. | IRVINE | CA | 92614-5821 |
| K024065 | GISH BIOMEDICAL, INC. |
11874 SOUTH EVELYN CIRCLE | HOUSTON | TX | 77071 |
| K050195 | GISH BIOMEDICAL, INC. |
11874 SOUTH EVELYN CIRCLE | HOUSTON | TX | 77071 |
| K031150 | GLOBAL BLOOD RESOURCES, LLC |
998 WINDSOR AVE. | WINDSOR | CT | 06095 |
| K003551 | JOSTRA AG |
17511 ARMSTRONG AVE. | IRVINE | CA | 92614-5686 |
| K070605 | MAQUET CARDIOPULMONARY AG |
HECHINGER STRASSE 38 | HIRRLINGEN | 72145 | |
| K141432 | MAQUET CARDIOPULMONARY AG |
KEHLER STRASSE 31 | RASTATT | 76437 | |
| K102919 | MAQUET CARDIOPULMONARY AG |
HECHINGER STRASSE 38 | HIRRLINGEN | 72145 | |
| K090534 | MAQUET CARDIOPULMONARY AG |
HECHINGER STRASSE 38 | HIRRLINGEN | 72145 | |
| K061743 | MAQUET CARDIOPULMONARY AG |
HECHINGER STRASSE 38 | HIRRLINGEN | 72145 | |
| K132166 | MAQUET CARDIOPULMONARY AG |
KEHLER STRASSE 31 | RASTATT | 76437 | |
| K090690 | MAQUET CARDIOPULMONARY AG |
HECHINGER STRASSE 38 | HIRRLINGEN | 72145 | |
| K241053 | Medtronic Cardiac Surgery |
8200 Coral Sea Street NE | Mounds View | MN | 55112 |
| K122914 | MEDTRONIC INC. |
7611 NORTHLAND DRIVE | MINNEAPOLIS | MN | 55428 |
| K031700 | MEDTRONIC PERFUSION SYSTEMS |
7611 NORTHLAND DR. | MINNEAPOLIS | MN | 55038 |
| K021287 | MEDTRONIC PERFUSION SYSTEMS |
7611 NORTHLAND DR. | MINNEAPOLIS | MN | 55038 |
| K961836 | MEDTRONIC VASCULAR |
4633 E. LA PALMA AVE. | ANAHEIM | CA | 92807 |
| K011864 | MEDTRONIC VASCULAR |
7611 NORTHLAND DR. | MINNEAPOLIS | MN | 55428 |
| K151110 | Medtronic, Inc |
7611 Northland Drive | Minneapolis | MN | 55428 |
| K132972 | MEDTRONIC, INC. |
7611 NORTHLAND DRIVE | MINNEAPOLIS | MN | 55428 |
| K141233 | MEDTRONIC, INC. |
7611 NORTHLAND DRIVE | MINNEAPOLIS | MN | 55428 |
| K170583 | Medtronic, Inc. |
7611 Northland Drive | Minneapolis | MN | 55428 |
| K953821 | MINNTECH CORP. |
14905 28TH AVE. N. | MINNEAPOLIS | MN | 55447 |
| K972017 | MINNTECH CORP. |
14605 28TH AVE. NORTH | MINNEAPOLIS | MN | 55447 |
| K002496 | PACE MEDICAL |
391 TOTTEN POND RD. | WALTHAM | MA | 02451 |
| K022281 | POLYSTAN A/S |
WALGERHOLM 8 | VAERLOSE | DK-3500 | |
| K982136 | SCHIFF & CO. |
1129 BLOOMFIELD AVE. | WEST CALDWELL | NJ | 07006 |
| K964907 | SORIN BIOMEDICAL, INC. |
17600 GILLETTE AVE. | IRVINE | CA | 92713-9503 |
| K964908 | SORIN BIOMEDICAL, INC. |
17600 GILLETTE AVE. | IRVINE | CA | 92713-9503 |
| K161733 | Sorin Group Italia S.r.l |
86, Via Statale 12 Nord | Mirandola | 41037 | |
| K100507 | SORIN GROUP ITALIA S.R.L |
PAREXEL CONSULTING | WALTHAM | MA | 02451 |
| K223361 | Sorin Group Italia S.R.L. |
Via Statale 12 Nord, 86 | Mirandola | 41037 | |
| K112771 | SORIN GROUP ITALIA S.R.L. |
14401 W. 65TH WAY | ARVADA | CO | 80004 |
| K061527 | SORIN GROUP ITALIA S.R.L. |
200 WEST STREET | WALTHAM | MA | 02451 |
| K092315 | SORIN GROUP ITALIA S.R.L. |
200 WEST STREET | WALTHAM | MA | 02451 |
| K131103 | SORIN GROUP ITALIA S.R.L. |
14401 W. 65TH WAY | ARVADA | CO | 80004 |
| K241206 | Spectrum Medical S.r.l. |
Via di Mezzo, 23 | Mirandola | 41037 | |
| K040023 | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K013526 | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K002238 | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K070839 | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K153143 | Terumo Cardiovascular Systems Corporation |
125 Blue Ball Road | Elkton | MD | 21921 |
| K033800 | Terumo Cardiovascular Systems Corporation |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K030449 | TERUMO CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K980935 | TERUMO MEDICAL CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K982223 | TERUMO MEDICAL CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K991973 | TERUMO MEDICAL CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
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