FDA 510(k) Applications for Medical Device:
Catheter, Peripheral, Atherectomy
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K990829 | ARROW INTL., INC. |
2400 BERNVILLE RD. | READING | PA | 19605 |
| K970080 | ARROW INTL., INC. |
3000 BERNVILLE RD. | READING | PA | 19605 |
| K140944 | ATHEROMED INC |
1455 ADAMS DRIVE SUITE 1120 | MENLO PARK | CA | 94025 |
| K132682 | ATHEROMED INC |
1455 ADAMS DRIVE SUITE 1110 | MENLO PARK | CA | 94025 |
| K162326 | Avinger, Inc |
400 Chesapeake Drive | Redwood City | CA | 94063 |
| K160827 | AVINGER, INC. |
400 CHESAPEAKE DRIVE | REDWOOD CITY | CA | 94063 |
| K172236 | Avinger, Inc. |
400 Chesapeake Drive | Redwood City | CA | 94063 |
| K163264 | Avinger, Inc. |
400 Chesapeake Drive | Redwood City | CA | 94063 |
| K153460 | AVINGER, INC. |
400 CHESAPEAKE DRIVE | REDWOOD CITY | CA | 94063 |
| K230005 | Avinger, Inc. |
400 Chesapeake Drive | Redwood City | CA | 94063 |
| K182341 | Avinger, Inc. |
400 Chesapeake Drive | Redwood City | CA | 94063 |
| K152275 | Avinger, Inc. |
400 Chesapeake Drive | Redwood City | CA | 94063 |
| K173862 | Avinger, Inc. |
400 Chesapeake Drive | Redwood City | CA | 94063 |
| K212047 | Avinger, Inc. |
400 Chesapeake Drive | Redwood City | CA | 94063 |
| K003570 | BACCHUS VASCULAR, INC. |
3110 CORONADO DR. | SANTA CLARA | CA | 95054 |
| K022640 | BACCHUS VASCULAR, INC. |
3110 CORONADO DR. | SANTA CLARA | CA | 95054 |
| K033997 | BACCHUS VASCULAR, INC. |
3110 CORONADO DR. | SANTA CLARA | CA | 95054 |
| K993816 | BAXTER EDWARDS |
17221 RED HILL AVE. | IRVINE | CA | 92614-5627 |
| K982363 | BOSTON SCIENTIFIC CORP. |
One Boston Scientific Place | Natick | MA | 01760 |
| K970296 | BOSTON SCIENTIFIC CORP. |
17425 N.E. UNION HILL RD. | REDMOND | WA | 98052-3376 |
| K121774 | BOSTON SCIENTIFIC CORP. |
ONE SCIMED PLACE | MAPLE GROVE | MN | 55311-1566 |
| K133566 | BOSTON SCIENTIFIC CORP. |
ONE SCIMED PLACE | MAPLE GROVE | MN | 55311-1566 |
| K220962 | Boston Scientific Corporation |
One Scimed Place | Maple Grove | MN | 55311 |
| K993648 | BOSTON SCIENTIFIC CORPORATION NORTHWEST TECHNOLOGY |
17425 N.E. UNION HILL RD. | REDMOND | WA | 98052 |
| K211738 | C.R. Bard, Inc. |
1625 West 3rd St | Tempe | AZ | 85281 |
| K231538 | Cardio Flow, Inc. |
3530 88th Ave NE | Blaine | MN | 55014 |
| K081944 | CARDIO SYSTEMS, INC. |
651 CAMPUS DRIVE | SAINT PAUL | MN | 55112-3495 |
| K131092 | CARDIO SYSTEMS, INC. |
651 CAMPUS DRIVE | SAINT PAUL | MN | 55112-3495 |
| K220568 | Cardiovascualr Systems Inc. |
1225 Old Highway 8 NW | New Brighton | MN | 55112 |
| K151260 | Cardiovascular System, Inc. |
1228 Old Highway 8 NW | Saint Paul | MN | 55112 |
| K210586 | Cardiovascular Systems Inc. |
1225 Old Highway 8 NW | New Brighton | MN | 55112 |
| K152694 | Cardiovascular Systems Inc. |
1225 Old Highway 8 NW | Saint Paul | MN | 55112 |
| K182397 | Cardiovascular Systems Inc. |
1225 Old Highway 8 NW | St. Paul | MN | 55112 |
| K203008 | Cardiovascular Systems Inc. |
1225 Old Highway 8 NW | Saint Paul | MN | 55112 |
| K220109 | Cardiovascular Systems Inc. |
1225 Old Highway 8 NW | Saint Paul | MN | 55112 |
| K190634 | Cardiovascular Systems Inc. |
1225 Old Highway 8 NW | St. Paul | MN | 55112 |
| K180416 | Cardiovascular Systems Inc. |
1225 Old Highway 8 NW | Saint Paul | MN | 55112 |
| K133399 | CARDIOVASCULAR SYSTEMS INCORPORATED |
651 CAMPUS DR. | SAINT PAUL | MN | 55112 |
| K041630 | CARDIOVASCULAR SYSTEMS INCORPORATED |
800 LEVANGER LANE | STOUGHTON | WI | 53589 |
| K090521 | CARDIOVASCULAR SYSTEMS, INC. |
651 CAMPUS DR. | ST. PAUL | MN | 55112 |
| K072800 | CARDIOVASCULAR SYSTEMS, INC. |
18555 37TH AVE N | PLYMOUTH | MN | 55446 |
| K071350 | CARDIOVASCULAR SYSTEMS, INC. |
651 CAMPUS DR. | ST. PAUL | MN | 55112 |
| K071427 | CARDIOVASCULAR SYSTEMS, INC. |
651 CAMPUS DR. | ST. PAUL | MN | 55112 |
| K082981 | CARDIOVASCULAR SYSTEMS, INC. |
651 CAMPUS DR. | ST. PAUL | MN | 55112 |
| K170792 | Cardiovascular Systems, Inc. |
1225 Old Highway 8 NW | Saint Paul | MN | 55112 |
| K133999 | CARDIOVASCULAR SYSTEMS, INC. |
651 CAMPUS DRIVE | SAINT PAUL | MN | 55112 |
| K150732 | CARDIOVASCULAR SYSTEMS, INC. |
651 CAMPUS DRIVE | SAINT PAUL | MN | 55112 |
| K111388 | CARDIOVASCULAR SYSTEMS, INC. |
651 CAMPUS DR. | ST. PAUL | MN | 55112 |
| K072748 | CARDIOVASCULAR SYSTEMS, INC. |
18555 37TH AVE N | PLYMOUTH | MN | 55446 |
| K110389 | CARDIOVASCULAR SYSTEMS, INC. |
651 CAMPUS DR | SAINT PAUL | MN | 55112 |
| K122987 | CARDIOVASCULAR SYSTEMS, INC. |
651 CAMPUS DR. | ST. PAUL | MN | 55112 |
| K141801 | COVIDIEN, LLC |
3033 CAMPUS DRIVE | PLYMOUTH | MN | 55442 |
| K021096 | EV3 CORPORATION |
4600 NATHAN LN. | PLYMOUTH | MN | 55442-2920 |
| K093301 | EV3 INC |
3033 Campus Drive | Plymouth | MN | 55441 |
| K111723 | EV3 INC |
3033 Campus Drive | Plymouth | MN | 55441 |
| K103618 | EV3 INC |
3033 Campus Drive | Plymouth | MN | 55441 |
| K220116 | Eximo Medical Ltd. |
Pekeris St 3 | Rehovot | 7670203 | |
| K202835 | Eximo Medical Ltd. |
Pekeris St 3 | Rehovot | 7670203 | |
| K221077 | Eximo Medical Ltd. |
Pekeris St 3 | Rehovot | 7670203 | |
| K230709 | Eximo Medical Ltd. |
Pekeris St 3 | Rehovot | 7670203 | |
| K181642 | Eximo Medical Ltd. |
3 Pekeris St. | Rehovot | 7670203 | |
| K053460 | FOX HOLLOW TECHNOLOGIES |
740 BAY ROAD | REDWOOD CITY | CA | 94063 |
| K024243 | FOX HOLLOW TECHNOLOGIES |
300 SAGINAW DR. | REDWOOD CITY | CA | 94063 |
| K043553 | FOX HOLLOW TECHNOLOGIES |
300 SAGINAW DR. | REDWOOD CITY | CA | 94063 |
| K071432 | FOX HOLLOW TECHNOLOGIES |
740 BAY ROAD | REDWOOD CITY | CA | 94063 |
| K061063 | FOXHOLLOW TECHNOLOGIES, INC. |
740 BAY ROAD | REDWOOD CITY | CA | 94063 |
| K061188 | FOXHOLLOW TECHNOLOGIES, INC. |
740 BAY ROAD | REDWOOD CITY | CA | 94063 |
| K970233 | GARY A. GELBFISH |
12300 TWINBROOK PKWY. | ROCKVILLE | MD | 20852 |
| K954604 | HEART TECHNOLOGY MFG., INC. |
17425 N.E. UNION HILL RD. | REDMOND | WA | 98052 |
| K960379 | HEART TECHNOLOGY MFG., INC. |
17425 N.E. UNION HILL RD. | REDMOND | WA | 98052 |
| K030504 | IDEV TECHNOLOGIES, INC. |
1110 NASA RD., SUITE 311 | HOUSTON | TX | 77058-3345 |
| K060016 | KENSEY NASH CORP. |
735 PENNSYLVANIA AVE. | EXTON | PA | 19341 |
| K072195 | KENSEY NASH CORP. |
735 PENNSYLVANIA DRIVE | EXTON | PA | 19341 |
| K122916 | MEDRAD, INC. |
10801 120TH AVENUE NE | KIRKLAND | WA | 98033 |
| K130637 | MEDRAD, INC. |
10801 120TH AVENUE NE | KIRKLAND | WA | 98033 |
| K133023 | MEDRAD, INC. |
9055 EVERGREEN BLVD. NW | MINNEAPOLIS | MN | 55433 |
| K161361 | Medtronic Vascular, Inc. |
(formerly d.b.a ev3 Inc., Covidien llc) | Plymouth | MN | 55441 |
| K170191 | MEDTRONIC VASCULAR, INC. |
3033 CAMPUS DRIVE | PLYMOUTH | MN | 55441 |
| K212027 | Medtronic, Inc |
4600 Nathan Lane North | Plymouth | MN | 55442 |
| K963925 | MICRO THERAPEUTICS, INC. |
1062-F CALLE NEGOCIO | SAN CLEMENTE | CA | 92673 |
| K973669 | MICRO THERAPEUTICS, INC. |
1062-F CALLE NEGOCIO | SAN CLEMENTE | CA | 92673 |
| K982657 | MICROVENA CORP. |
1861 BUERKLE RD. | WHITE BEAR LAKE | MN | 55110-5426 |
| K971984 | MICROVENA CORP. |
1861 BUERKLE RD. | WHITE BEAR LAKE | MN | 55110-5426 |
| K954205 | MICROVENA CORP. |
1861 BUERKLE RD. | WHITE BEAR LAKE | MN | 55110-5426 |
| K091509 | PATHWAY MEDICAL TECHNOLOGIES, INC. |
10801 120TH AVENUE NE | KIRKLAND | WA | 98033 |
| K083837 | PATHWAY MEDICAL TECHNOLOGIES, INC. |
10801 120TH AVENUE NE | KIRKLAND | WA | 98033 |
| K090325 | PATHWAY MEDICAL TECHNOLOGIES, INC. |
10801 120TH AVENUE NE | KIRKLAND | WA | 98033 |
| K111229 | PATHWAY MEDICAL TECHNOLOGIES, INC. |
10801 120TH AVENUE NE | KIRKLAND | WA | 98033 |
| K093918 | PATHWAY MEDICAL TECHNOLOGIES, INC. |
10801 120TH AVENUE NE | KIRKLAND | WA | 98033 |
| K100462 | PATHWAY MEDICAL TECHNOLOGIES, INC. |
10801 120TH AVENUE NE | KIRKLAND | WA | 98033 |
| K101334 | PATHWAY MEDICAL TECHNOLOGIES, INC. |
10801 120TH AVENUE NE | KIRKLAND | WA | 98033 |
| K093456 | PATHWAY MEDICAL TECHNOLOGIES, INC. |
10801 120TH AVENUE NE | KIRKLAND | WA | 98033 |
| K092332 | PATHWAY MEDICAL TECHNOLOGIES, INC. |
10801 120TH AVENUE NE | KIRKLAND | WA | 98033 |
| K101221 | PATHWAY MEDICAL TECHNOLOGIES, INC. |
10801 120TH AVENUE NE | KIRKLAND | WA | 98033 |
| K120242 | PATHWAY MEDICAL TECHNOLOGIES, INC. |
10801 120TH AVENUE NE | KIRKLAND | WA | 98033 |
| K110626 | PATHWAY MEDICAL TECHNOLOGIES, INC. |
10801 120TH AVENUE NE | KIRKLAND | WA | 98033 |
| K083489 | PATHWAY MEDICAL TECHNOLOGIES, INC. |
10801 120TH AVENUE NE | KIRKLAND | WA | 98033 |
| K082664 | PATHWAY MEDICAL TECHNOLOGIES, INC. |
10801 120TH AVENUE NE | KIRKLAND | WA | 98033 |
| K082186 | PATHWAY MEDICAL TECHNOLOGIES, INC. |
10801 120TH AVENUE NE | KIRKLAND | WA | 98033 |
| K081328 | PATHWAY MEDICAL TECHNOLOGIES, INC. |
10801 120TH AVENUE NE | KIRKLAND | WA | 98033 |
| K960970 | POSSIS MEDICAL, INC. |
2905 NORTHWEST BLVD. | MINNEAPOLIS | MN | 55441-2644 |
| K993564 | POSSIS MEDICAL, INC. |
9055 EVERGREEN BLVD., N.W. | MINNEAPOLIS | MN | 55433-8003 |
| K033793 | REX MEDICAL |
55 Northern Blvd. | Great Neck | NY | 11021 |
| K120346 | REX MEDICAL |
55 Northern Blvd. | Great Neck | NY | 11021 |
| K091029 | REX MEDICAL |
55 Northern Blvd. | Great Neck | NY | 11021 |
| K040252 | REX MEDICAL |
55 Northern Blvd. | Great Neck | NY | 11021 |
| K031610 | REX MEDICAL |
55 Northern Blvd. | Great Neck | NY | 11021 |
| K060904 | REX MEDICAL LP |
55 Northern Blvd. | Great Neck | NY | 11021 |
| K212351 | Rex Medical, L.P. |
555 East North Lane, Suite 5035 | Conshohocken | PA | 19428 |
| K191419 | Rex Medical, L.P. |
555 East North Lane, Suite 5035 | Conshohocken | PA | 19428 |
| K123632 | SPECTRANETICS CORP. |
9965 Federal Drive | Colorado Springs | CO | 80921 |
| K094036 | SPECTRANETICS CORP. |
9965 Federal Drive | Colorado Springs | CO | 80921 |
| K140775 | SPECTRANETICS CORPORATION |
9965 FEDERAL DRIVE | COLORADO SPRINGS | CO | 80921-3617 |
| K222837 | Spectranetics Inc. |
9965 Federal Drive | Colorado Springs | CO | 80921 |
| K170059 | Spectranetics, Inc. |
9965 Federal Drive | Colorado Springs | CO | 80921 |
| K162561 | SPECTRANETICS, INC. |
9965 FEDERAL DRIVE | COLORADO SPRINGS | CO | 80921 |
| K172687 | Spectranetics, Inc. |
9965 Federal Drive | Colorado Springs | CO | 80921 |
| K180694 | Spectranetics, Inc. |
9965 Federal Drive | Colorado Springs | CO | 80921 |
| K152181 | SPECTRANETICS, INC. |
9965 FEDERAL DRIVE | COLORADO SPRINGS | CO | 80921 |
| K172315 | Straub Medical AG |
Straubstrasse 12 | Wangs | ch 7323 | |
| K172386 | Volcano AtheroMed Inc |
1530 O'Brien Drive | Menlo Park | CA | 94025 |
| K181877 | Volcano AtheroMed Inc. |
1530 O'Brien Drive | Menlo Park | CA | 94025 |
| K182972 | Volcano AtheroMed Inc. |
1530 O'Brien Drive, Suite A | Menlo Park | CA | 94025 |
| K143328 | Volcano AtheroMed, Inc. |
1455 Adams Drive, Suite 1120 | Menlo Park | CA | 94025 |
| K151145 | Volcano AtheroMed, Inc. |
1455 Adams Drive, Suite 1120 | Menlo Park | CA | 94025 |
| K211518 | Volcano AtheroMed, Inc. |
1530 O'Brien Drive, Suite A | Menlo Park | CA | 94025 |
| K013473 | XTRAK MEDICAL INC. |
7 TIFFANY TRAIL | HOPKINTON | MA | 01748 |
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