FDA 510(k) Applications for Medical Device:
Tubing, Pump, Cardiopulmonary Bypass
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K142607 | ANGIODYNAMICS |
26 FOREST STREET | MARLBOROUGH | MA | 01752 |
| K981613 | COBE CARDIOVASCULAR, INC. |
14401 WEST 65TH WAY | ARVADA | CO | 80004 |
| K233702 | Livanova USA Inc |
14401 West 65th Way | Arvada | CO | 80004 |
| K080592 | MAQUET CARDIOPULMONARY AG |
HECHINGER STRASSE 38 | HIRRLINGEN | 72145 | |
| K053025 | MAQUET CARDIOPULMONARY AG |
P.O. BOX 2042 | FAIRFIELD | IA | 52556 |
| K993062 | OLSON MEDICAL SALES, INC. |
2101 COTTONTAIL LN. | SOMERSET | NJ | 08873 |
| K013578 | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K022857 | Terumo Cardiovascular Systems Corporation |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K150542 | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION |
28 HOWE STREET | ASHLAND | MA | 01721 |
| K993189 | TERUMO CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K092486 | VORTEX MEDICAL INC |
42 HORICON AVE. | GLENS FALLS | NY | 12801 |
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