FDA 510(k) Applications for Medical Device:
Catheter, Intravascular Occluding, Temporary
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K221294 | Abiomed Inc. |
22 Cherry Hill Drive | Danvers | MA | 01923 |
| K143613 | ACCESSCLOSURE, INC. |
5452 Besty Ross Drive | Santa Clara | CA | 95054 |
| K993248 | AGA MEDICAL CORP. |
682 MENDELSSOHN AVE. | GOLDEN VALLEY | MN | 55427 |
| K053440 | AGA MEDICAL CORP. |
682 MENDELSSOHN AVE. | GOLDEN VALLEY | MN | 55427 |
| K192786 | Arch Catheter, LLC |
621 Grand Harbor Boulevard | Ninety Six | SC | 29666 |
| K021210 | ARTERIA MEDICAL SCIENCE, INC. |
22 HILL ST. | NEWBURYPORT | MA | 01950 |
| K001917 | ARTERIA MEDICAL SCIENCE, INC. |
P.O. BOX 3515 | REDMOND | WA | 98073-3515 |
| K183045 | Balt USA, LLC |
29 Parker | Irvine | CA | 92618 |
| K140273 | BOSTON SCIENTIFIC CORP. |
ONE SCIMED PLACE | MAPLE GROVE | MN | 55311-1566 |
| K132990 | BOSTON SCIENTIFIC CORP. |
ONE SCIMED PLACE | MAPLE GROVE | MN | 55311-1566 |
| K993292 | BOSTON SCIENTIFIC, TARGET |
47900 BAYSIDE PKWY. | FREMONT | CA | 94538 |
| K964390 | CHASE MEDICAL, INC. |
1876 FIRMAN DR. | RICHARDSON | TX | 75081 |
| K023914 | COAXIA INC |
10900 73RD AVE. N. | MAPLE GROVE | MN | 55369 |
| K090970 | COAXIA, INC. |
10900 73RD AVE. N. | MAPLE GROVE | MN | 55369 |
| K002286 | COOK, INC. |
925 SOUTH CURRY PIKE | BLOOMINGTON | IN | 47402 |
| K211610 | Edwards Lifesciences, LLC |
One Edwards Way | Irvine | CA | 92614 |
| K093911 | EDWARDS LIFESCIENCES, LLC. |
ONE EDWARDS WAY | IRVINE | CA | 92614 |
| K152762 | EDWARDS LIFESCIENCES, LLC. |
ONE EDWARDS WAY | IRVINE | CA | 92614 |
| K180904 | Embolx, Inc |
530 Lakeside, Suite 200 | Sunnyvale | CA | 94085 |
| K142692 | EMBOLX, INC. |
5760 Arboretum Drive | Los Altos | CA | 94024 |
| K100063 | EV3 INC |
9775 TOLEDO WAY | IRVINE | CA | 92618 |
| K090728 | EV3 INC. |
9775 TOLEDO WAY | IRVINE | CA | 92618 |
| K091458 | EV3 NEUROVASCULAR |
9775 TOLEDO WAY | IRVINE | CA | 92618 |
| K092495 | EV3 NEUROVASCULAR |
9775 TOLEDO WAY | IRVINE | CA | 92618 |
| K201652 | Front Line Medical Technologies, Inc. |
184 Paul Street, Unit 1 | London | n6hil2 | |
| K960422 | IDEAS FOR MEDICINE, INC. |
12167 49TH ST. NORTH | CLEARWATER | FL | 34622 |
| K960715 | IDEAS FOR MEDICINE, INC. |
12167 49TH ST. NORTH | CLEARWATER | FL | 34622 |
| K960832 | INTERVENTIONAL THERAPEUTICS CORP. |
48668 MILMONT DR. | FREMONT | CA | 94538 |
| K182916 | LeMaitre Vascular |
63 Second Avenue | Burlington | MA | 01803 |
| K143454 | LeMaitre Vascular, Inc |
63 Second Avenue | Burlington | MA | 01803 |
| K071367 | LEMAITRE VASCULAR, INC. |
63 2ND AVENUE | BURLINGTON | MA | 01803 |
| K132022 | LEMAITRE VASCULAR, INC. |
63 2ND AVENUE | BURLINGTON | MA | 01803 |
| K033159 | LEMAITRE VASCULAR, INC. |
63 2ND AVENUE | BURLINGTON | MA | 01803 |
| K103356 | LEMAITRE VASCULAR, INC. |
63 2ND AVENUE | BURLINGTON | MA | 01803 |
| K051067 | LEMAITRE VASCULAR, INC. |
63 2ND AVENUE | BURLINGTON | MA | 01803 |
| K152833 | LEMAITRE VASCULAR, INC. |
63 SECOND AVENUE | BURLINGTON | MA | 01803 |
| K043023 | LEMAITRE VASCULAR, INC. |
63 2ND AVENUE | BURLINGTON | MA | 01803 |
| K955499 | LUCAS MEDICAL, INC. |
1751 SOUTH DOUGLASS RD. | ANAHEIM | CA | 92806 |
| K983802 | LUCAS MEDICAL, INC. |
1751 SOUTH DOUGLASS RD. | ANAHEIM | CA | 92806 |
| K994141 | MEDTRONIC AVE, INC. |
3576 UNOCAL PL. | SANTA ROSA | CA | 95403 |
| K101570 | MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR |
9775 TOLEDO WAY | IRVINE | CA | 92618 |
| K011535 | MICRO THERAPEUTICS, INC. |
2 GOODYEAR | IRVINE | CA | 92618 |
| K001237 | MICRO THERAPEUTICS, INC. |
2 GOODYEAR | IRVINE | CA | 92618 |
| K990487 | MICRO THERAPEUTICS, INC. |
2 GOODYEAR | IRVINE | CA | 92618 |
| K010162 | MICRO THERAPEUTICS, INC. |
2 GOODYEAR | IRVINE | CA | 92618 |
| K011656 | MICRO THERAPEUTICS, INC. |
2 GOODYEAR | IRVINE | CA | 92618 |
| K011526 | MICRO THERAPEUTICS, INC. |
2 GOODYEAR | IRVINE | CA | 92618 |
| K021066 | MICRO THERAPEUTICS, INC. |
2 GOODYEAR | IRVINE | CA | 92618 |
| K121785 | MICRO VENTION, INC. |
1311 VALENCIA AVENUE | TUSTIN | CA | 92780 |
| K113698 | MICRO VENTION, INC. |
1311 VALENCIA AVENUE | TUSTIN | CA | 92780 |
| K110741 | MICROVENTION, INC. |
1311 VALENCIA AVE | TUSTIN | CA | 92780 |
| K080861 | MICRUS ENDOVASCULAR CORPORATION |
821 FOX LANE | SAN JOSE | CA | 95131 |
| K103780 | MICRUS ENDOVASCULAR CORPORATION |
821 FOX LANE | SAN JOSE | CA | 95131 |
| K091504 | MICRUS ENDOVASCULAR CORPORATION |
821 FOX LANE | SAN JOSE | CA | 95131 |
| K210358 | Neurescue Aps |
Kobmagergade 53, 2 | Copenhagen | 1150 | |
| K041306 | NUMED, INC. |
2880 MAIN ST. | HOPKINTON | NY | 12965 |
| K003320 | NUMED, INC. |
2880 MAIN ST. | HOPKINTON | NY | 12965 |
| K110903 | NUMED, INC. |
2880 MAIN ST. | HOPKINTON | NY | 12965 |
| K131869 | NUMED, INC. |
2880 MAIN ST. | HOPKINTON | NY | 12965 |
| K160598 | NUMED, INC. |
2880 MAIN STREET | HOPKINTON | NY | 12965 |
| K972777 | PERCUSURGE, INC. |
777 N. PASTORIA AVE. | SUNNYVALE | CA | 94086 |
| K081454 | POSSIS MEDICAL, INC. |
9055 EVERGREEN BLVD., N.W. | MINNEAPOLIS | MN | 55433-8003 |
| K031357 | POSSIS MEDICAL, INC. |
9055 EVERGREEN BLVD., N.W. | MINNEAPOLIS | MN | 55433-8003 |
| K062220 | POSSIS MEDICAL, INC. |
9055 EVERGREEN BLVD., N.W. | MINNEAPOLIS | MN | 55433-8003 |
| K170411 | Prytime Medical Devices, Inc |
229 North Main Street | Boerne | TX | 78006 |
| K193440 | Prytime Medical Devices, Inc |
229 North Main Street | Boerne | TX | 78006 |
| K172790 | Prytime Medical Devices, Inc. |
229 North Main Street | Boerne | TX | 78006 |
| K200459 | Prytime Medical Devices, Inc. |
229 North Main Street | Boerne | TX | 78006 |
| K183679 | QXMedical, LLC |
2820 Patton Road | Roseville | MN | 55113 |
| K210602 | RenalPro Medical, Inc. |
2370-B Walsh Avenue | Santa Clara | CA | 95051 |
| K191606 | RenovoRx, Inc. |
4546 El Camino Real, Suite 223 | Los Altos | CA | 94022 |
| K160067 | RenovoRx, Inc. |
4546 El Camino Real, Suite 282 | Los Altos | CA | 94022 |
| K212324 | RenovoRx, Inc. |
4546 El Camino Real, Suite B1 | Los Altos | CA | 94022 |
| K141175 | RENOVORX, INC. |
755 N. MATHILDA AVE, STE 100 | SUNNYVALE | CA | 94085 |
| K052844 | RICHTER & ROTHE AG |
WILHELM LEUSCHNER PLATZ 12 | LEIPZIG | 04107 | |
| K153530 | SPECTRANETICS, INC. |
9965 FEDERAL DRIVE | COLORADO SPRINGS | CO | 80921 |
| K203540 | Spectranetics, Inc. |
9965 Federal Drive | Colorado Springs | CO | 80921 |
| K122576 | STRYKER NEUROVASCULAR |
47900 BAYSIDE PARKWAY | FREMONT | CA | 94538 |
| K051137 | TECHDEVICE CORPORATION |
650 PLEASANT ST. | WATERTOWN | MA | 02472 |
| K093847 | THERMOPEUTIX INC. |
9925B BUSINESS PARK AVE. | SAN DIEGO | CA | 92131 |
| K080700 | THERMOPEUTIX INC. |
9925B BUSINESS PARK AVE. | SAN DIEGO | CA | 92131 |
| K112219 | THERMOPEUTIX INC. |
9925B BUSINESS PARK AVE. | SAN DIEGO | CA | 92131 |
| K001621 | VASCUTECH, INC. |
164 MIDDLESEX TURNPIKE | BURLINGTON | MA | 01803 |
| K992942 | VASCUTECH, INC. |
164 MIDDLESEX TURNPIKE | BURLINGTON | MA | 01803 |
| K070770 | W. L. GORE & ASSOCIATES, INC. |
2647 LIN GATE COURT | PLEASANTON | CA | 94566 |
| K172567 | W.L Gore And Associates Inc |
1505 N. Fourth Street | Flagstaff | AZ | 86004 |
| K214060 | Zien Medical Technologies, Inc. |
2757 South 300 West Suite F | Salt Lake City | UT | 84115 |
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