FDA 510(k) Applications for Medical Device:
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K982254 | COBE CARDIOVASCULAR, INC. |
14401 WEST 65TH WAY | ARVADA | CO | 80004 |
| K002493 | COBE CARDIOVASCULAR, INC. |
14401 WEST 65TH WAY | ARVADA | CO | 80004 |
| K040184 | COBE CARDIOVASCULAR, INC. |
14401 WEST 65TH WAY | ARVADA | CO | 80004 |
| K031323 | CONVERGENZA AG |
3625 WOODLAKE DR. | BONITA SPRINGS | FL | 34134 |
| K041061 | DIDECO S.P.A. |
195 WEST ST. | WALTHAM | MA | 02451-1163 |
| K033987 | DIDECO S.P.A. |
195 WEST ST. | WALTHAM | MA | 02451-1163 |
| K051232 | DIDECO S.R.L. |
195 WEST STREET | WALTHAM | MA | 02451 |
| K052717 | DIDECO S.R.L. |
200 WEST STREET | WALTHAM | MA | 02451 |
| K062429 | EDWARDS LIFESCIENCES RESEARCH MEDICAL |
6864 SOUTH 300 WEST | MIDVALE | UT | 84047 |
| K031946 | EDWARDS LIFESCIENCES, LLC. |
1635A SOUTH MAIN STREET | MILPITAS | CA | 94043 |
| K022071 | EMBOL-X, INC. |
645 CLYDE AVE. | MOUNTAIN VIEW | CA | 94043 |
| K023833 | GISH BIOMEDICAL, INC. |
11874 SOUTH EVELYN CIRCLE | HOUSTON | TX | 77071 |
| K081054 | GISH BIOMEDICAL, INC. |
11874 SOUTH EVELYN CIRCLE | HOUSTON | TX | 77071 |
| K001787 | JOSTRA MEDIZINTECHNIK AG |
2035 SUNSET LAKE RD. | NEWARK | DE | 19702 |
| K082544 | MAQUET CARDIOPULMONARY AG |
HECHINGER STRASSE 38 | HIRRLINGEN | 72145 | |
| K061546 | MAQUET CARDIOPULMONARY AG |
HECHINGER STRASSE 38 | HIRRLINGEN | 72145 | |
| K090518 | MAQUET CARDIOPULMONARY AG |
HECHINGER STRASSE 38 | HIRRLINGEN | 72145 | |
| K122760 | MEDTRONIC INC. |
7611 NORTHLAND DRIVE | MINNEAPOLIS | MN | 55428 |
| K100646 | MEDTRONIC INC. |
7611 NORTHLAND DRIVE | MINNEAPOLIS | MN | 55428 |
| K994208 | MEDTRONIC PERFUSION SYSTEMS |
7611 NORTHLAND DR. | MINNEAPOLIS | MN | 55038 |
| K033468 | MEDTRONIC PERFUSION SYSTEMS |
7611 NORTHLAND DR. | MINNEAPOLIS | MN | 55038 |
| K013084 | MEDTRONIC PERFUSION SYSTEMS |
7611 NORTHLAND DR. | MINNEAPOLIS | MN | 55038 |
| K123351 | MEDTRONIC PERFUSION SYSTEMS |
7611 NORTHLAND DR. | MINNEAPOLIS | MN | 55432 |
| K001138 | MEDTRONIC VASCULAR |
4633 E. LA PALMA AVE. | ANAHEIM | CA | 92807 |
| K071253 | MEDTRONIC VASCULAR |
7611 NORTHLAND DR. | MINNEAPOLIS | MN | 55428 |
| K000379 | MEDTRONIC VASCULAR |
4633 E. LA PALMA AVE. | ANAHEIM | CA | 92807 |
| K980762 | PALL CORP. |
2200 NORTHERN BLVD. | EAST HILLS | NY | 11548 |
| K112525 | PAREXELINTERNATIONAL |
195 WEST STREET | WALTHAM | MA | 02451 |
| K961869 | SORIN BIOMEDICAL, INC. |
17600 GILLETTE AVE. | IRVINE | CA | 92713-9503 |
| K063255 | SORIN GROUP ITALIA S.R.L |
200 WEST STREET | WALTHAM | MA | 02451 |
| K093986 | SORIN GROUP ITALIA S.R.L. |
195 WEST STREET | WALTHAM | MA | 02451 |
| K093601 | SORIN GROUP ITALIA S.R.L. |
195 WEST STREET | WALTHAM | MA | 02451 |
| K072308 | SORIN GROUP ITALIA S.R.L. |
200 WEST STREET | WALTHAM | MA | 02451 |
| K052205 | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K011804 | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K032128 | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K083747 | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K083834 | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K121209 | Terumo Cardiovascular Systems Corporation |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K002026 | TERUMO MEDICAL CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
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