FDA 510(k) Applications for Medical Device:
Oxygenator, Cardiopulmonary Bypass
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K222297 | Abbott |
6035 Stoneridge Drive | Pleasanton | CA | 94588 |
| K200109 | Abiomed Inc. |
22 Cherry Hill Drive | Danvers | MA | 01923 |
| K223161 | Abiomed Inc. |
22 Cherry Hill Drive | Danvers | MA | 01923 |
| K130520 | ASHITAKA FACTORY OF TERUMO CORP. |
150 MAIMAIGI-CHO | FUJINOMIYA, SHIZUOKA | 418-0015 | |
| K973760 | AVECOR CARDIOVASCULAR, INC. |
7611 NORTHLAND DR. | MINNEAPOLIS | MN | 55428 |
| K954850 | C.R. BARD, INC. |
25 COMPUTER DR. | HAVERHILL | MA | 01832 |
| K153295 | CARDIAC ASSIST, INC. |
240 ALPHA DR. | PITTSBURGH | PA | 15238 |
| K191246 | Chalice Medical Ltd |
Manton Wood Enterprise Park, | Worksop | S80 2RS | |
| K201642 | Chalice Medical Ltd |
Manton Wood Enterprise Park | Worksop | S80 2RS | |
| K964043 | COBE CARDIOVASCULAR, INC. |
14401 WEST 65TH WAY | ARVADA | CO | 80004 |
| K963518 | COBE CARDIOVASCULAR, INC. |
14401 WEST 65TH WAY | ARVADA | CO | 80004 |
| K991452 | COBE CARDIOVASCULAR, INC. |
14401 WEST 65TH WAY | ARVADA | CO | 80004 |
| K974085 | COBE CARDIOVASCULAR, INC. |
14401 WEST 65TH WAY | ARVADA | CO | 80004 |
| K000255 | COBE CARDIOVASCULAR, INC. |
14401 WEST 65TH WAY | ARVADA | CO | 80004 |
| K013480 | COBE CARDIOVASCULAR, INC. |
14401 WEST 65TH WAY | ARVADA | CO | 80004 |
| K974812 | COBE CARDIOVASCULAR, INC. |
14401 WEST 65TH WAY | ARVADA | CO | 80004 |
| K010478 | DIDECO |
14401 W. 65th Way | Arvada | CO | 80004-3599 |
| K004001 | DIDECO |
14401 W. 65th Way | Arvada | CO | 80004-3599 |
| K014080 | DIDECO S.P.A. |
195 WEST ST. | WALTHAM | MA | 02451-1163 |
| K020997 | DIDECO S.P.A. |
195 WEST ST. | WALTHAM | MA | 02451-1163 |
| K020351 | DIDECO S.P.A. |
195 WEST ST. | WALTHAM | MA | 02451-1163 |
| K033323 | DIDECO S.P.A. |
195 WEST ST. | WALTHAM | MA | 02451-1163 |
| K013915 | DIDECO S.P.A. |
14401 WEST 65TH WAY | ARVADA | CO | 80004-3599 |
| K022450 | DIDECO S.P.A. |
195 WEST ST. | WALTHAM | MA | 02451-1163 |
| K971877 | DIDECO S.P.A. |
1601 TRAPELO RD. | WALTHAM | MA | 02154 |
| K001021 | DIDECO S.P.A. |
195 WEST ST. | WALTHAM | MA | 02451-1163 |
| K991737 | DIDECO S.P.A. |
1601 TRAPELO RD. | WALTHAM | MA | 02154 |
| K031223 | DIDECO S.P.A. |
195 WEST ST. | WALTHAM | MA | 02451-1163 |
| K043323 | DIDECO S.R.L. |
195 WEST ST. | WALTHAM | MA | 02451 |
| K953835 | DIDECO S.R.L. |
200 WEST STREET | WALTHAM | MA | 02451 |
| K050447 | DIDECO S.R.L. |
195 WEST ST. | WALTHAM | MA | 02451 |
| K141492 | EUROSETS S.R.L. |
VIA G. PUCCINI, 1 | MEDOLLA, MODENA | I-43036 | |
| K102109 | EUROSETS S.R.L. |
VIA G. PUCCINI, 1 | MEDOLLA, MODENA | I-43036 | |
| K202510 | Eurosets S.r.l. |
Strada Statale 12, n░143 | Medolla | I-41036 | |
| K202206 | Eurosets S.r.l. |
Strada Statale 12, n░143 | Medolla | i-41036 | |
| K961530 | GISH BIOMEDICAL, INC. |
2681 KELVIN AVE. | IRVINE | CA | 92614-5821 |
| K090449 | GISH BIOMEDICAL, INC. |
22942 ARROYO VISTA | RANCHO SANTA MARGARITA | CA | 92688 |
| K082403 | GISH BIOMEDICAL, INC. |
11874 SOUTH EVELYN CIRCLE | HOUSTON | TX | 77071 |
| K090450 | GISH BIOMEDICAL, INC. |
22942 ARROYO VISTA | RANCHO SANTA MARGARITA | CA | 92688 |
| K023381 | GISH BIOMEDICAL, INC. |
11874 SOUTH EVELYN CIRCLE | HOUSTON | TX | 77071 |
| K080708 | GISH BIOMEDICAL, INC. |
11874 SOUTH EVELYN CIRCLE | HOUSTON | TX | 77071 |
| K031903 | GUIDANT CORPORATION |
4100 HAMLINE AVE NORTH | ST PAUL | MN | 55112-5798 |
| K030264 | JOSTRA AG |
HECHINGER STRASSE 38 | HIRRLINGEN | 72145 | |
| K992559 | JOSTRA BENTLEY |
2035 SUNSET LAKE RD. | NEWARK | DE | 19702 |
| K071774 | MAQUET CARDIOPULMONARY AG |
HECHINGER STRASSE 38 | HIRRLINGEN | 72145 | |
| K061628 | MAQUET CARDIOPULMONARY AG |
414 MARYJOE WAY | WARRINGTON | PA | 18976 |
| K090511 | MAQUET CARDIOPULMONARY AG |
HECHINGER STRASSE 38 | HIRRLINGEN | 72145 | |
| K082117 | MAQUET CARDIOPULMONARY AG |
HECHINGER STRASSE 38 | HIRRLINGEN | 72145 | |
| K150267 | MAQUET CARDIOPULMONARY AG |
KEHLER STRASSE 31 | RASTATT | 76437 | |
| K112360 | MAQUET CARDIOPULMONARY AG |
HECHINGER STRASSE 38 | HIRRLINGEN | 72145 | |
| K102464 | MAQUET CARDIOPULMONARY AG |
HECHINGER STRASSE 38 | HIRRLINGEN | 72145 | |
| K103191 | MAQUET CARDIOPULMONARY AG |
HECHINGER STRASSE 38 | HIRRLINGEN | 72145 | |
| K093522 | MAQUET CARDIOPULMONARY AG |
HECHINGER STRASSE 38 | HIRRLINGEN | 72145 | |
| K090689 | MAQUET CARDIOPULMONARY AG |
HECHINGER STRASSE 38 | HIRRLINGEN | 72145 | |
| K132829 | MAQUET CARDIOPULMONARY AG |
45 BARBOUR POND DRIVE | WAYNE | NJ | 07470 |
| K101153 | MAQUET CARDIOPULMONARY AG |
HECHINGER STRASSE 38 | HIRRLINGEN | 72145 | |
| K100278 | MAQUET CARDIOPULMONARY AG |
HECHINGER STRASSE 38 | HIRRLINGEN | 72145 | |
| K133261 | MEDOS MEDIZINTECHNIK AG |
3526 WEST LIBERTY RD. | ANN ARBOR | MI | 48103 |
| K140181 | MEDOS MEDIZINTECHNIK AG |
3526 WEST LIBERTY RD. | ANN ARBOR | MI | 48103 |
| K140177 | MEDOS MEDIZINTECHNIK AG |
3526 WEST LIBERTY RD. | ANN ARBOR | MI | 48103 |
| K203111 | Medtronic |
7611 Northland Drive | Minneapolis | MN | 55428 |
| K183490 | Medtronic Inc |
7611 Northland Dr | Minneapolis | MN | 55428 |
| K183511 | Medtronic Inc |
7611 Northland Dr | Minneapolis | MN | 55428 |
| K122827 | MEDTRONIC INC. |
7611 NORTHLAND DRIVE | MINNEAPOLIS | MN | 55428 |
| K123314 | MEDTRONIC INC. |
7611 NORTHLAND DRIVE | MINNEAPOLIS | MN | 55428 |
| K230640 | Medtronic Inc. |
7611 Northland Drive | Minneapolis | MN | 55428 |
| K100645 | MEDTRONIC INC. |
7611 NORTHLAND DRIVE | MINNEAPOLIS | MN | 55428 |
| K992910 | MEDTRONIC VASCULAR |
4633 EAST LA PALMA AVE. | ANAHEIM | CA | 92807 |
| K000430 | MEDTRONIC VASCULAR |
4633 EAST LA PALMA AVE. | ANAHEIM | CA | 92807 |
| K962641 | MEDTRONIC VASCULAR |
4633 E. LA PALMA AVE. | ANAHEIM | CA | 92807 |
| K984271 | MEDTRONIC VASCULAR |
4633 E. LA PALMA AVE. | ANAHEIM | CA | 92807 |
| K142784 | Medtronic, Inc |
8200 Coral Sea Street NE | Mounds View | MN | 55112 |
| K172626 | Medtronic, Inc. |
8200 Coral Sea Street NE | Mounds View | MN | 55112 |
| K191444 | Medtronic, Inc. |
7611 Northland Drive | Minneapolis | MN | 55428 |
| K162016 | MEDTRONIC, INC. |
8200 CORAL SEA STREET NE (MVS83) | MOUNDS VIEW | MN | 55112 |
| K162896 | MEDTRONIC, INC. |
8200 CORAL SEA STREET NE (MVS83) | MOUNDS VIEW | MN | 55112 |
| K143073 | Medtronic, Inc. |
7611 Northland Drive | Minneapolis | MN | 55428 |
| K191029 | Medtronic, Inc. |
7611 Northland Drive | Minneapolis | MN | 55428 |
| K172984 | Medtronic, Inc. |
8200 Coral Sea Street NE | Mounds View | MN | 55112 |
| K964967 | MINNTECH CORP. |
14605 28TH AVE. NORTH | MINNEAPOLIS | MN | 55447 |
| K072362 | NOVALUNG GMBH |
49 PLAIN STREET | NORTH ATTLEBORO | MA | 02760 |
| K013038 | POLYSTAN A/S |
WALGERHOLM 8 | VAERLOSE | DK-3500 | |
| K953976 | POLYSTAN A/S |
WALGERHOLM 8 | VAERLOSE | DK-3500 | |
| K980974 | POLYSTAN A/S |
WALGERHOLM 8 | VAERLOSE | DK-3500 | |
| K203424 | Qura S.r.l. |
Via di Mezzo, 23 | Mirandola | 41037 | |
| K212341 | Qura S.r.l. |
Via di Mezzo, 23 | Mirandola | 41037 | |
| K990103 | SORIN BIOMEDICAL, INC. |
17600 GILLETTE AVE. | IRVINE | CA | 92614-5751 |
| K211495 | Sorin Group Italia S.R.L |
Via Statale 12 Nord. 86 | Mirandola | 41037 | |
| K201916 | Sorin Group Italia S.r.l |
Via Statale 12 Nord, 86 | Mirandola | 41037 | |
| K180448 | Sorin Group Italia S.r.l |
86, Via Statale 12 Nord | Mirandola | 41037 | |
| K092895 | SORIN GROUP ITALIA S.R.L. |
195 WEST STREET | WALTHAM | MA | 02451 |
| K083021 | SORIN GROUP ITALIA S.R.L. |
200 WEST STREET | WALTHAM | MA | 02451 |
| K061031 | SORIN GROUP ITALIA S.R.L. |
200 WEST STREET | WALTHAM | MA | 02451 |
| K072091 | SORIN GROUP ITALIA S.R.L. |
200 WEST STREET | WALTHAM | MA | 02451 |
| K150489 | SORIN GROUP ITALIA S.R.L. |
86, VIA STATALE 12 NORD | MIRANDOLA, MO | 41037 | |
| K121909 | SORIN GROUP ITALIA S.R.L. |
14401 W. 65TH WAY | ARVADA | CO | 80004 |
| K130209 | SORIN GROUP ITALIA S.R.L. |
14401 W. 65TH WAY | ARVADA | CO | 80004 |
| K113626 | SORIN GROUP ITALIA S.R.L. |
195 WEST STREET | WALTHAM | MA | 02451 |
| K120185 | SORIN GROUP ITALIA S.R.L. |
195 WEST STREET | WALTHAM | MA | 02451 |
| K190690 | SORIN GROUP ITALIA S.R.L. |
Via Statale 12 Nord, 86 | Mirandola | 41037 | |
| K200683 | Sorin Group Italia S.R.L. |
Via Statale 12 Nord, 86 | Mirandola | 41037 | |
| K121229 | SORIN GROUP ITALIA S.R.L. |
195 WEST STREET | WALTHAM | MA | 02451 |
| K130433 | SORIN GROUP ITALIA S.R.L. |
14401 W. 65TH WAY | ARVADA | CO | 80004 |
| K122254 | SORIN GROUP ITALIA S.R.L. |
14401 W. 65TH WAY | ARVADA | CO | 80004 |
| K122844 | SORIN GROUP ITALIA S.R.L. |
14401 W. 65TH WAY | ARVADA | CO | 80004 |
| K121536 | SORIN GROUP ITALIA S.R.L. |
14401 W. 65TH WAY | ARVADA | CO | 80004 |
| K151713 | SORIN GROUP ITALIA S.R.L. |
86, VIA STATALE 12 NORD | MIRANDOLA | 41037 | |
| K073380 | SORIN GROUP ITALIA S.R.L. |
200 WEST STREET | WALTHAM | MA | 02451 |
| K062381 | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K051997 | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K010443 | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K130359 | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K130333 | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K153140 | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
125 BLUE BALL ROAD | ELKTON | MD | 21921 |
| K153213 | Terumo Cardiovascular Systems Corporation |
125 Blue Ball Road | Elkton | MD | 21921 |
| K151389 | Terumo Cardiovascular Systems Corporation |
125 Blue Ball Road | Elkton | MD | 21921 |
| K151791 | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION |
125 BLUE BALL ROAD | ELKTON | MD | 21921 |
| K140774 | Terumo Cardiovascular Systems Corporation |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K172071 | Terumo Cardiovascular Systems Corporation |
125 Blue Ball Road | Elkton | MD | 21921 |
| K180950 | Terumo Cardiovascular Systems Corporation |
125 Blue Ball Road | Elkton | MD | 21921 |
| K071572 | TERUMO CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K071494 | TERUMO CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K022115 | TERUMO CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K040210 | TERUMO CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K130280 | TERUMO Corporation |
125 Blue Ball Road | Elkton | MD | 21921 |
| K130493 | TERUMO Corporation |
125 Blue Ball Road | Elkton | MD | 21921 |
| K961734 | TERUMO MEDICAL CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K970463 | TERUMO MEDICAL CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K960074 | TERUMO MEDICAL CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K961000 | TERUMO MEDICAL CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K962667 | TERUMO MEDICAL CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K993772 | TERUMO MEDICAL CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
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