FDA 510(k) Applications for Medical Device:
Control, Pump Speed, Cardiopulmonary Bypass
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K200306 | Abbott (formerly Thoratec Corporation) |
6035 Stoneridge Drive | Pleasanton | CA | 94588 |
| K230698 | APMTD Inc. |
226 Lowell Street, Unit B16 | Wilmington | MA | 01887 |
| K221491 | APMTD, Inc. |
226 Lowell Street, Unit B16 | Wilmington | MA | 01887 |
| K971421 | C.R. BARD, INC. |
25 COMPUTER DR. | HAVERHILL | MA | 01832 |
| K061369 | CARDIAC ASSIST, INC. |
240 ALPHA DR. | PITTSBURGH | PA | 15238 |
| K232788 | Inspira Technologies Oxy B.H.N Ltd. |
2 Ha-Tidhar St. | Ra'anana | 4366504 | |
| K102129 | LEVITRONIX LLC. |
45 FIRST AVE. | WALTHAM | MA | 02451 |
| K093832 | LEVITRONIX LLC. |
45 FIRST AVE. | WALTHAM | MA | 02451 |
| K053630 | LEVITRONIX LLC. |
45 FIRST AVE. | WALTHAM | MA | 02451 |
| K081221 | LEVITRONIX LLC. |
45 FIRST AVE. | WALTHAM | MA | 02451 |
| K083340 | LEVITRONIX LLC. |
45 FIRST AVE. | WALTHAM | MA | 02451 |
| K090004 | LEVITRONIX LLC. |
45 FIRST AVE. | WALTHAM | MA | 02451 |
| K070286 | Medtronic |
7611 NORTHLAND DRIVE | MINNEAPOLIS | MN | 55428 |
| K131964 | MEDTRONIC INC. |
8200 Coral Sea Street NE | Mounds View | MN | 55112 |
| K080824 | MEDTRONIC PERFUSION SYSTEMS |
7611 NORTHLAND DR. | MINNEAPOLIS | MN | 55432 |
| K051303 | MEDTRONIC PERFUSION SYSTEMS |
7611 NORTHLAND DR. N | MINNEAPOLIS | MN | 55428 |
| K112225 | SORIN GROUP DEUTSCHLAND GMBH |
49 PLAIN STREET | NORTH ATTLEBORO | MA | 02760 |
| K103468 | SORIN GROUP DEUTSCHLAND GMBH |
49 PLAIN STREET | NORTH ATTLEBORO | MA | 02760 |
| K091008 | SORIN GROUP DEUTSCHLAND GMBH |
49 PLAIN STREET | NORTH ATTLEBORO | MA | 02760 |
| K192838 | Spectrum Medical Ltd |
Harrier 4, Meteor Business Park, Cheltenham Road East | Gloucester | GL2 9QL | |
| K011838 | STOCKERT INSTRUMENTE GMBH |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K032213 | STOCKERT INSTRUMENTE GMBH |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K042374 | STOCKERT INSTRUMENTE GMBH |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K131179 | THORATEC CORP |
23 4th Ave | BURLINGTON | MA | 01803 |
| K191557 | Thoratec Corporation (now part of Abbott) |
6035 Stoneridge Drive | Pleasanton | CA | 94588 |
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