FDA 510(k) Applications for Medical Device:
Device, Vascular, For Promoting Embolization
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K220567 | ABK Biomedical Inc |
155 Chain Lake Drive | Halifax | B3S 1B3 | |
| K234123 | ABK Biomedical Inc |
155 Chain Lake Drive | Halifax | B3S 1B3 | |
| K031810 | AGA MEDICAL CORP. |
682 MENDELSSOHN AVE. | GOLDEN VALLEY | MN | 55427 |
| K113658 | AGA MEDICAL CORP. |
5050 NATHAN LANE NORTH | PLYMOUTH | MN | 55442 |
| K071125 | AGA MEDICAL CORP. |
5050 NATHAN LANE NORTH | PLYMOUTH | MN | 55442 |
| K071699 | AGA MEDICAL CORP. |
5050 NATHAN LANE NORTH | PLYMOUTH | MN | 55442 |
| K213200 | Artio Medical, Inc. |
127 Independence Drive | Menlo Park | CA | 94025 |
| K133924 | ARTVENTIVE MEDICAL GROUP, INC |
24125 85TH AVENUE SE | WOODINVILLE | WA | 98072 |
| K150402 | ARTVENTIVE MEDICAL GROUP, INC |
2766 Gateway Road | Carlsbad | CA | 92009 |
| K212057 | ArtVentive Medical Group, Inc. |
1797 Playa Vista | San Marcos | CA | 92708 |
| K220699 | Bait USA, LLC |
29 Parker | Irvine | CA | 92618 |
| K251383 | Balt USA, LLC |
29 Parker | Irvine | CA | 92618 |
| K083091 | BIOCOMPATIBLES U.K. LIMITED |
20310 SW 48TH STREET | FT. LAUDERDALE | FL | 33332 |
| K162373 | Biocompatibles UK Limited |
Chapman House, Farnham Business Park, Weydon Lane | Farnham | GU9 8QL | |
| K150876 | BIOCOMPATIBLES UK LTD |
CHAPMAN HOUSE, WEYDON LANE | FARNHAM, SURREY | GU9 8QL | |
| K152157 | BIOCOMPATIBLES UK LTD |
Chapman House, Farnham Business Park, Weydon Lane | Farnham | GU9 8QL | |
| K043371 | BIOMERIX CORPORATION |
1700 ROCKVILLE PIKE | ROCKVILE | MD | 20852 |
| K151187 | BIOSPHERE MEDICAL S.A. |
PARC DES NATIONS - PARIS NORD 2, 383 RUE DE LA BELLE ETOILE | ROISSY-EN-FRANCE | 95700 | |
| K052742 | BIOSPHERE MEDICAL, INC. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K181021 | Biosphere Medical, S.A. |
Parc des Nations û Paris Nord 2, 383 rue de la Belle Etoile | Roissy en France | 95700 | |
| K183120 | Biosphere Medical, S.A. |
Parc des Nations û Paris Nord 2, 383 rue de la Belle Etoile | Roissy en France | 95700 | |
| K250971 | Biosphere Medical, S.A. |
Parc des Nations Paris Nord 2 | Roissy-en-France | 95700 | |
| K181300 | Biosphere Medical, S.A. |
Parc des Nations û Paris Nord 2, 383 rue de la Belle Etoile | Roissy en France | 95700 | |
| K172372 | Biosphere Medical, S.A. |
Parc des Nations û Paris Nord 2, 383 rue de la Belle Etoile | Roissy en France | 95700 | |
| K153102 | BIOSPHERE MEDICAL, S.A. |
Parc des Nations-Paris Nord 2, 383 rue de la Belle Etoile | Roissy en France | 95700 | |
| K183578 | Biosphere Medical, S.A. |
Parc des Nations û Paris Nord 2, 383 rue de la Belle Etoile | Roissy en France | 95700 | |
| K192480 | Biosphere Medical, S.A. |
Parc des Nations û Paris Nord 2, 383, rue de la Belle Etoile | Roissy-en-France | 95700 | |
| K242507 | Boston Scientific |
1 Scimed Place | Maple Grove | MN | 55311 |
| K102714 | BOSTON SCIENTIFIC CORP. |
ONE SCIMED PLACE | MAPLE GROVE | MN | 55311 |
| K034068 | BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. | NATICK | MA | 01760-1537 |
| K132578 | BOSTON SCIENTIFIC CORP. |
ONE SCIMED PLACE | MAPLE GROVE | MN | 55311-1566 |
| K112103 | BOSTON SCIENTIFIC CORP. |
ONE SCIMED PLACE | MAPLE GROVE | MN | 55311 |
| K110295 | BOSTON SCIENTIFIC CORP. |
ONE SCIMED PLACE | MAPLE GROVE | MN | 55311-1566 |
| K133208 | BOSTON SCIENTIFIC CORP. |
ONE SCIMED PLACE | MAPLE GROVE | MN | 55311-1566 |
| K040342 | BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. | NATICK | MA | 01760-1537 |
| K213398 | Boston Scientific Corporation |
One Scimed Place | Maple Grove | MN | 55311 |
| K230706 | Boston Scientific Corporation |
300 Boston Scientific Way | Boston | MA | 01752 |
| K060078 | Boston Scientific Corporation |
100 BOSTON SCIENTFIC WAY | MARLBOROUGH | MA | 01752 |
| K141378 | Boston Scientific Corporation |
ONE SCIMED PLACE | MAPLE GROVE | MN | 55311-1566 |
| K113651 | Boston Scientific Corporation |
ONE SCIMED PLACE | MAPLE GROVE | MN | 55311 |
| K102912 | BOSTONSCIENTIFIC |
ONE SCIMED PLACE | MAPLE GROVE | MN | 55311-1566 |
| K191532 | C. R. Bard, Inc. |
Moyne Upper | Emniscorthy | ||
| K073417 | CELONOVA BIOSCIENCES, INC. |
49 SPRING ST. | NEWMAN | GA | 30263 |
| K130307 | CELONOVA BIOSCIENCES, INC. |
18615 TUSCANY STONE | SAN ANTONIO | TX | 78258 |
| K141209 | CELONOVA BIOSCIENCES, INC. |
18615 Tuscany Stone Ste 100 | San Antonio | TX | 78258 |
| K132675 | CELONOVA BIOSCIENCES, INC. |
18615 Tuscany Stone Ste 100 | San Antonio | TX | 78258 |
| K050470 | CONCENTRIC MEDICAL, INC. |
1380 SHOREBIRD WAY | MOUNTAIN VIEW | CA | 94043 |
| K160219 | Cook Incorporated |
750 Daniels Way | Bloomington | IN | 47404 |
| K150931 | Cook Incorporated |
750 Daniels Way | Bloomington | IN | 47404 |
| K150964 | Cook Incorporated |
750 Daniels Way | Bloomington | IN | 47402 |
| K153778 | COOK INCORPORATED |
750 DANIELS WAY | BLOOMINGTON | IN | 47404 |
| K123712 | COOK INCORPORATED |
750 DANIELS WAY | BLOOMINGTON | IN | 47402 |
| K151676 | COOK INCORPORATED |
750 DANIELS WAY | BLOOMINGTON | IN | 47404 |
| K090624 | COOK, INC. |
750 DANIELS WAY | BLOOMINGTON | IN | 47404 |
| K992121 | COOK, INC. |
925 SOUTH CURRY PK | BLOOMINGTON | IN | 47403-2624 |
| K993455 | COOK, INC. |
P.O. BOX 489 | BLOOMINGTON | IN | 47402 |
| K063619 | COOK, INC. |
750 DANIELS WAY | BLOOMINGTON | IN | 47402 |
| K052834 | COOK, INC. |
750 DANIELS WAY | BLOOMINGTON | IN | 47402 |
| K171845 | EMBA Medical Limited |
3451 Commerce Pkwy | Miramar | FL | 33025 |
| K200083 | Embolic Acceleration, LLC |
3451 Commerce Pkwy | Miramar | FL | 33025 |
| K250276 | Embolization Inc. |
5421 Western Ave. | Boulder | CO | 80301 |
| K123696 | ENDOSHAPE, INC. |
2450 Central Ave Ste I | Boulder | CO | 80301 |
| K140796 | ENDOSHAPE, INC. |
2450 Central Ave Ste I | Boulder | CO | 80301 |
| K232934 | Hangzhou Yangshun Medical Technology Co.,Ltd |
Room 110,Building 2,No.357 Miaohouwang Road | Hangzhou | 310000 | |
| K093813 | IMBIOTECHNOLOGIES |
49 PLAIN STREET | NORTH ATTLEBORO | MA | 02760 |
| K240873 | Instylla, Inc. |
201 Burlington Rd | Bedford | MA | 01730 |
| K182944 | KA Medical, LLC |
2890 Centre Pointe Drive | Roseville | MN | 55113 |
| K212817 | Merit Medical System, Inc. |
1600 West Merit Parkway | South Jordan | UT | 84095 |
| K240261 | Merit Medical Systems, Inc. |
1600 Merit Pkwy Bldg 87 | South Jordan | UT | 84095 |
| K081465 | MICRO THERAPEUTICS, INC. |
9775 TOLEDO WAY | IRVINE | CA | 92618 |
| K090046 | MICRO THERAPEUTICS, INC. |
9775 TOLEDO WAY | IRVINE | CA | 92618 |
| K202850 | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
9775 Toledo Way | Irvine | CA | 92618 |
| K151358 | Micro Vention, Inc. |
1311 Valencia Avenue | Tustin | CA | 92780 |
| K120630 | MICRO VENTION, INC. |
1311 VALENCIA AVENUE | TUSTIN | CA | 92780 |
| K132083 | MICRO VENTION, INC. |
1311 VALENCIA AVENUE | TUSTIN | CA | 92780 |
| K223050 | MicroVention Inc. |
35 Enterprise | Aliso Viejo | CA | 92656 |
| K191680 | MicroVention Inc. |
35 Enterprise | Aliso Viejo | CA | 92656 |
| K162524 | MicroVention, Inc |
1311 Valencia Avenue | Tustin | CA | 92780 |
| K123384 | MICROVENTION, INC. |
1311 VALENCIA AVE | TUSTIN | CA | 92780 |
| K122316 | MICROVENTION, INC. |
1311 VALENCIA AVE | TUSTIN | CA | 92780 |
| K111307 | MICROVENTION, INC. |
1311 VALENCIA AVE | TUSTIN | CA | 92780 |
| K091882 | MICROVENTION, INC. |
75 COLUMBIA | ALISO VIEJO | CA | 92656-1408 |
| K093002 | MICROVENTION, INC. |
1311 VALENCIA AVE | TUSTIN | CA | 92780 |
| K122543 | MICROVENTION, INC. |
1311 VALENCIA AVE | TUSTIN | CA | 92780 |
| K133626 | MICROVENTION, INC. |
1311 VALENCIA AVE | TUSTIN | CA | 92780 |
| K130577 | MICROVENTION, INC. |
1311 VALENCIA AVE | TUSTIN | CA | 92780 |
| K071939 | MICROVENTION, INC. |
75 COLUMBIA | ALISO VIEJO | CA | 92656-1408 |
| K150870 | MICROVENTION, INC. |
1311 VALENCIA AVE | TUSTIN | CA | 92780 |
| K150958 | MicroVention, Inc. |
1311 Valencia Ave. | Tustin | CA | 92780 |
| K102365 | MICROVENTION, INC. |
75 COLUMBIA | ALISO VIEJO | CA | 92656-1408 |
| K091952 | NFOCUS NEUROMEDICAL, INC. |
2191 E. BAYSHORE ROAD | PALO ALTO | CA | 94303 |
| K250133 | Nuvascular Inc. |
141 Innovation Drive, Suite 100 | Irvine | CA | 92617 |
| K213385 | Obsidio, Inc. |
1520 Main Street, Unit 4-C | Columbia | SC | 29201 |
| K203025 | Okami Medical |
8 Argonut Suite 100 | Aliso Viejo | CA | 92656 |
| K220383 | Okami Medical |
8 Argonut Suite 100 | Aliso Viejo | CA | 92656 |
| K192083 | Okami Medical |
8 Argonaut, Suite 100 | Aliso Viejo | CA | 92656 |
| K250079 | Penumbra, Inc. |
One Penumbra Place | Alameda | CA | 94502 |
| K061790 | PROTEIN POLYMER TECHNOLOGIES, INC. |
10655 SORRENTO VALLEY RD. | SAN DIEGO | CA | 92121 |
| K133282 | REVERSE MEDICAL CORPORATION |
13700 Alton Parkway | Irvine | CA | 92618 |
| K123803 | REVERSE MEDICAL CORPORATION |
13700 ALTON PARKWAY SUITE 167 | IRVINE | CA | 92618 |
| K141313 | REVERSE MEDICAL CORPORATION |
13700 Alton Parkway | Irvine | CA | 92618 |
| K150108 | REVERSE MEDICAL CORPORATION |
13700 ALTON PARKWAY, SUITE 167 | IRVINE | CA | 92618 |
| K073544 | RJ MEDICAL, INC. |
4921 ROBERT J. MATHEWS PKWY | EL DORADO HILLS | CA | 95762 |
| K181051 | Shape Memory Medical |
807 Aldo Avenue, Suite 109 | Santa Clara | CA | 95054 |
| K182390 | Shape Memory Medical |
807 Aldo Avenue, Suite 109 | Santa Clara | CA | 95054 |
| K120816 | Stryker |
47900 BAYSIDE PARKWAY | FREMONT | CA | 94538 |
| K231554 | Suzhou Haowei Medical Technology Co., Ltd. |
Room 304, Building 4, Tianyun Square, No.111 Wusongjiang | Suzhou | 215124 | |
| K210562 | Suzhou Hengrui Hongyuan Medical Co., Ltd. |
Building B9 Unit 201, No. 218 Xinghu Road, SIP, | Suzhou | 215123 | |
| K964112 | TARGET THERAPEUTICS |
47201 LAKEVIEW BLVD. | FREEMONT | CA | 94538 |
| K955293 | TARGET THERAPEUTICS |
47201 LAKEVIEW BLVD. | FREEMONT | CA | 94538 |
| K242608 | Varian Medical Systems, Inc. |
3100 Hansen Way | Palo Alto | CA | 94304 |
| K242794 | Varian Medical Systems, Inc. |
3100 Hansen Way | Palo Alto | CA | 94304 |
| K171946 | Vascular Solutions, Inc. |
6464 Sycamore Court North | Minneapolis | MN | 55369 |
| K173891 | Vascular Solutions, Inc. |
6464 Sycamore Court N | Minneapolis | MN | 55369 |
| K133237 | VASCULAR SOLUTIONS, INC. |
6464 Sycamore Court North | Minneapolis | MN | 55369 |
| K143038 | VASCULAR SOLUTIONS, INC. |
6464 SYCAMORE COURT NORTH | MINNEAPOLIS | MN | 55369 |
| K113266 | VASCULAR SOLUTIONS, INC. |
6464 Sycamore Court North | Minneapolis | MN | 55369 |
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