FDA 510(k) Applications for Medical Device:
Temporary Carotid Catheter For Embolic Capture
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K110909 | ABBOTT LABORATORIES |
3200 Lakeside Drive | Santa Clara | CA | 95054 |
| K081549 | ABBOTT LABORATORIES |
3200 Lakeside Drive | Santa Clara | CA | 95054 |
| K121015 | Abbott Vascular |
3200 Lakeside Drive | Santa Clara | CA | 95054 |
| K141678 | Abbott Vascular |
3200 Lakeside Drive | Santa Clara | CA | 95054 |
| K191173 | Abbott Vascular |
3200 Lakeside Drive | Santa Clara | CA | 95054 |
| K153086 | ABBOTT VASCULAR |
3200, LAKESIDE DRIVE | SANTA CLARA | CA | 95054 |
| K052454 | ABBOTT VASCULAR DEVICES |
400 SAGINAW DR. | REDWOOD CITY | CA | 94063 |
| K081523 | ABBOTT VASCULAR-VASCULAR SOLUTIONS |
3200 LAKESIDE DR. | SANTA CLARA | CA | 95054 |
| K090665 | ABBOTT VASCULAR-VASCULAR SOLUTIONS |
3200 LAKESIDE DR. | SANTA CLARA | CA | 95054 |
| K063313 | BOSTON SCIENTIFIC CORP. |
2011 STIERLIN CT. | MOUNTAIN VIEW | CA | 94043 |
| K210282 | Cardiovascular Systems Inc. |
1225 Old Hwy 8 NW | St. Paul | MN | 55112 |
| K200198 | Cardiovascular Systems, Inc |
1225 Old Hwy 8 NW | Saint Paul | MN | 55112 |
| K101651 | CORDIS CORP. |
430 ROUTE 22 EAST | BRIDGEWATER | NJ | 08807 |
| K062531 | CORDIS CORP., A JOHNSON & JOHNSON CO. |
7 POWDERHORN DRIVE | WARREN | NJ | 07059 |
| K220654 | Cordis Corporation |
14201 N.W. 60th Avenue | Miami Lakes | FL | 33014 |
| K111010 | EV3 INC |
3033 Campus Drive | Plymouth | MN | 55441 |
| K063204 | EV3 INC |
9600 54TH AVENUE NORTH | PLYMOUTH | MN | 55442-2920 |
| K052659 | EV3 INC |
4600 NATHAN LN. NORTH | PLYMOUTH | MN | 55442 |
| K143570 | GARDIA MEDICAL |
2 Ha'Eshel Street | Caesarea | 38900 | |
| K180023 | Gardia Medical Ltd. |
HaEshel 2 | Caesarea | 3088900 | |
| K042218 | GUIDANT CORP. |
3200 LAKESIDE DR. | SANTA CLARA | CA | 95054-2807 |
| K042908 | GUIDANT CORP. |
3200 LAKESIDE DR. | SANTA CLARA | CA | 95054-2807 |
| K052166 | GUIDANT CORPORATION |
3200 Lakeside Drive | Santa Clara | CA | 95054 |
| K052165 | GUIDANT CORPORATION |
3200 Lakeside Drive | Santa Clara | CA | 95054 |
| K092177 | INVATEC S.P.A. |
3101 EMRICK BLVD | BETHLEHEM | PA | 18020 |
| K111987 | LUMEN BIOMEDICAL, INC. |
10900 73RD AVE NORTH | MAPLE GROVE | MN | 55369 |
| K082348 | LUMEN BIOMEDICAL, INC. |
14505 21ST AVE. NORTH | PLYMOUTH | MN | 55447 |
| K072990 | MEDTRONIC INC. |
37A CHERRY HILL DRIVE | DANVERS | MA | 01923 |
| K222694 | MicroVention, Inc. |
35 Enterprise | Aliso Viejo | CA | 92656 |
| K230402 | Silk Road Medical |
1213 Innsbruck Drive | Sunnyvale | CA | 94089 |
| K143072 | SILK ROAD MEDICAL, INC |
735 NORTH PASTORIA AVE | SUNNYVALE | CA | 94085 |
| K153485 | SILK ROAD MEDICAL, INC. |
735 NORTH PASTORIA AVENUE | SUNNYVALE | CA | 94085 |
| K123156 | W. L. GORE & ASSOCIATES, INC. |
32360 N NORTH VALLEY PARKWAY | PHOENIX | AZ | 85085 |
| K120480 | W.L. GORE & ASSOCIATES |
4250 WEST KILTIE LN | FLAGSTAFF | AZ | 86001 |
| K103500 | W.L. GORE & ASSOCIATES,INC |
4250 WEST KILTIE LANE | FLAGSTAFF | AZ | 86001 |
| K083300 | W.L. GORE & ASSOCIATES,INC |
3250 W. KILTIE LANE | FLAGSTAFF | AZ | 86005 |
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