FDA 510(k) Applications for Medical Device:
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K992443 | ATRIUM MEDICAL CORP. |
5 WENTWORTH DR. | HUDSON | NH | 03051 |
| K992960 | ATRIUM MEDICAL CORP. |
5 WENTWORTH DR. | HUDSON | NH | 03051 |
| K020767 | ATRIUM MEDICAL CORP. |
5 WENTWORTH DR. | HUDSON | NH | 03051 |
| K010517 | ATRIUM MEDICAL CORP. |
5 WENTWORTH DR. | HUDSON | NH | 03051 |
| K010516 | ATRIUM MEDICAL CORP. |
5 WENTWORTH DR. | HUDSON | NH | 03051 |
| K000499 | ATRIUM MEDICAL CORP. |
5 WENTWORTH DR. | HUDSON | NH | 03051 |
| K051332 | ATRIUM MEDICAL CORP. |
5 WENTWORTH DR. | HUDSON | NH | 03051 |
| K060124 | ATRIUM MEDICAL CORP. |
5 WENTWORTH DR. | HUDSON | NH | 03051 |
| K122138 | ATRIUM MEDICAL CORP. |
5 WENTWORTH DR | HUDSON | NH | 03051 |
| K102596 | ATRIUM MEDICAL CORP. |
5 WENTWORTH DR. | HUDSON | NH | 03051 |
| K071923 | ATRIUM MEDICAL CORP. |
5 WENTWORTH DR. | HUDSON | NH | 03051 |
| K013577 | ATRIUM MEDICAL CORP. |
5 WENTWORTH DR. | HUDSON | NH | 03051 |
| K963790 | ATRIUM MEDICAL CORP. |
5 WENTWORTH DR. | HUDSON | NH | 03051 |
| K991813 | ATRIUM MEDICAL CORP. |
5 WENTWORTH DR. | HUDSON | NH | 03051 |
| K130142 | ATRIUM MEDICAL CORPORATION |
5 WENTWORTH DR | HUDSON | NH | 03051 |
| K050049 | BARD PERIPHERAL VASCULAR, INC. |
1625 WEST 3RD ST. | TEMPE | AZ | 85281 |
| K052282 | BARD PERIPHERAL VASCULAR, INC. |
1415 WEST 3RD ST. | TEMPE | AZ | 85281 |
| K052964 | BOSTON SCIENTIFIC CORP. |
TWO SCIMED PLACE | MAPLE GROVE | MN | 55311-1566 |
| K113101 | Boston Scientific Corporation |
45 BARBOUR POND DRIVE | WAYNE | NJ | 07470 |
| K012952 | BOSTON SCIENTIFIC/MEDI-TECH |
ONE BOSTON SCIENTIFIC PLACE | NATICK | MA | 01760-1537 |
| K961134 | C.R. BARD, INC. |
25 COMPUTER DR. | HAVERHILL | MA | 01832 |
| K964665 | CARBOMEDICS, INC. |
1300 EAST ANDERSON LN. | AUSTIN | TX | 78752-1793 |
| K955588 | CARBOMEDICS, INC. |
1300 EAST ANDERSON LN. | AUSTIN | TX | 78752-1793 |
| K960706 | CARBOMEDICS, INC. |
1300 EAST ANDERSON LN. | AUSTIN | TX | 78752-1793 |
| K032900 | EDWARDS LIFESCIENCES, LLC. |
ONE EDWARDS WAY | IRVINE | CA | 92614 |
| K071778 | GRAFTCATH INC. |
6545 CITY WEST PARKWAY | EDEN PRAIRIE | MN | 55344 |
| K124039 | HEMOSHPERE, INC., A CRYOLIFE COMPANY |
6545 CITY WEST PARKWAY | EDEN PRAIRIE | MN | 55344 |
| K120006 | HEMOSPHERE INC |
6545 CITY WEST PARKWAY | EDEN PRAIRIE | MN | 55344 |
| K121532 | HEMOSPHERE INC |
6545 CITY WEST PARKWAY | EDEN PRAIRIE | MN | 55344 |
| K091491 | HEMOSPHERE INC |
6545 CITY WEST PARKWAY | EDEN PRAIRIE | MN | 55344 |
| K991027 | IMPRA, INC. |
1625 WEST 3RD ST. | TEMPE | AZ | 85281 |
| K983861 | IMPRA, INC. |
1625 WEST 3RD ST. | TEMPE | AZ | 85281 |
| K962639 | IMPRA, INC. |
1625 WEST 3RD ST. | TEMPE | AZ | 85281 |
| K964197 | IMPRA, INC. |
1625 WEST 3RD ST. | TEMPE | AZ | 85281 |
| K004011 | IMPRA, INC. |
1625 WEST 3RD ST. | TEMPE | AZ | 85281 |
| K971192 | IMPRA, INC. |
1625 WEST 3RD ST. | TEMPE | AZ | 85281 |
| K983064 | IMPRA, INC. |
1625 WEST 3RD ST. | TEMPE | AZ | 85281 |
| K981079 | IMPRA, INC. |
1625 WEST 3RD ST. | TEMPE | AZ | 85281 |
| K013651 | INTERVASCULAR |
20 WALNUT ST.; SUITE 12 | WELLESLEY | MA | 02481 |
| K022242 | INTERVASCULAR |
20 WALNUT ST. | WELLESLEY | MA | 02481 |
| K964625 | INTERVASCULAR, INC. |
16331 BAY VISTA DR. | CLEARWATER | FL | 33760-3130 |
| K990800 | INTERVASCULAR, INC. |
16331 BAY VISTA DR. | CLEARWATER | FL | 33760-3130 |
| K983819 | INTERVASCULAR, INC. |
16331 BAY VISTA DR. | CLEARWATER | FL | 33760-3130 |
| K970843 | INTERVASCULAR, INC. |
16331 BAY VISTA DR. | CLEARWATER | FL | 33760-3130 |
| K984294 | INTERVASCULAR, INC. |
16331 BAY VISTA DR. | CLEARWATER | FL | 33760-3130 |
| K103347 | INTERVASCULAR, SAS |
ZONE INDUSTRIELLE ATHELIA I | LACIOTAT | 13705 | |
| K021547 | JOTEC GMBH |
2430 N. 7TH AVE. STE 4 | BOZEMAN | MT | 59715 |
| K130016 | LEMAITRE VASCULAR, INC. |
63 2ND AVENUE | BURLINGTON | MA | 01803 |
| K131778 | MAQUET CARDIOVASCULAR LLC |
45 BARBOUR POND DRIVE | WAYNE | NJ | 07470 |
| K153523 | MAQUET CARDIOVASCULAR, LLC |
45 BARBOUR POND DRIVE | WAYNE | NJ | 07470 |
| K961847 | MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. |
103 BAUER DR. | OAKLAND | NJ | 07436 |
| K962433 | MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. |
15 THORNTON RD. | OAKLAND | NJ | 07436 |
| K955460 | MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. |
112 BAUER DR. | OAKLAND | NJ | 07436 |
| K172637 | Merit Medical Systems, Inc. |
1600 West Merit Parkway | South Jordan | UT | 84095 |
| K213845 | Merit Medical Systems, Inc. |
1600 West Merit Parkway | South Jordan | UT | 84095 |
| K203724 | Merit Medical Systems, Inc. |
1600 West Merit Parkway | South Jordan | UT | 84095 |
| K202471 | PECA Labs |
4424 Penn Ave, Suite 201 | Pittsburgh | PA | 15224 |
| K183613 | PECA Labs |
4424 Penn Ave, Suite 201 | Pittsburgh | PA | 15224 |
| K221628 | PECA Labs |
4424 Penn Ave, Suite 201 | Pittsburgh | PA | 15224 |
| K180957 | PECA Labs |
4424 Penn Ave, Suite 201 | Pittsburgh | PA | 15224 |
| K984182 | POSSIS MEDICAL, INC. |
9055 EVERGREEN BLVD., N.W. | MINNEAPOLIS | MN | 55433-8003 |
| K002007 | SULZER CARBOMEDICS, INC. |
1300 EAST ANDERSON LN. | AUSTIN | TX | 78752 |
| K013022 | SULZER CARBOMEDICS, INC. |
1300 EAST ANDERSON LN. | AUSTIN | TX | 78752 |
| K992832 | SULZER MEDICA |
1300 EAST ANDERSON LN. | AUSTIN | TX | 78752-1793 |
| K993667 | SULZER MEDICA |
1300 EAST ANDERSON LN. | AUSTIN | TX | 78752-1793 |
| K990503 | SULZERMEDICA |
1300 EAST ANDERSON LN. | AUSTIN | TX | 78752 |
| K061626 | SUNWEI TECH CO. LTD. |
7128 STAFFORDSHIRE STREET | HOUSTON | TX | 77030 |
| K083169 | TAYSIDE FLOW TECHNOLOGIES LIMITED |
1141 E. HAWKEN WAY | CHANDLER | AZ | 85286 |
| K094044 | TAYSIDE FLOW TECHNOLOGIES LIMITED |
1141 E. HAWKEN WAY | CHANDLER | AZ | 85286 |
| K001927 | THORATEC LABORATORIES CORP. |
6035 STONERIDGE DR. | PLEASANTON, | CA | 94588 |
| K142062 | VASCULAR FLOW TECHNOLOGIES LTD |
Prospect Business Centre | Dundee | DD2 1TY | |
| K150389 | VASCULAR FLOW TECHNOLOGIES LTD |
Prospect Business Centre | Dundee | DD2 1TY | |
| K141124 | VASCULAR FLOW TECHNOLOGIES LTD |
Prospect Business Centre | Dundee | DD2 1TY | |
| K202703 | Vascutek Ltd |
Newmains Avenue | Inchinnan | PA4 9RR | |
| K030999 | VASCUTEK LTD. |
6200 JACKSON RD. | ANN ARBOR | MI | 48103-9300 |
| K162803 | VASCUTEK LTD. |
NEWMAINS AVE, | INCHINNAN | PA4 9RR | |
| K034010 | VASCUTEK LTD. |
6200 JACKSON RD. | ANN ARBOR | MI | 48103-9300 |
| K040829 | VASCUTEK LTD. |
6200 JACKSON RD. | ANN ARBOR | MI | 48103-9300 |
| K093817 | VASCUTEK LTD. |
NEWMAINS AVE. | RENFREWSHIRE, GLASGOW | PA4 9RR | |
| K162794 | VASCUTEK LTD. |
NEWMAINS AVENUE | INCHINNAN | PA4 9RR | |
| K092863 | VASCUTEK LTD. |
NEWMAINS AVE. | RENFREWSHIRE, GLASGOW | PA4 9RR | |
| K041528 | VASCUTEK LTD. |
6200 JACKSON RD. | ANN ARBOR | MI | 48103-9300 |
| K090987 | VASCUTEK LTD. |
NEWMAINS AVE. | INCHINNAN, RENFREWSHIRE | PA4 9RR | |
| K091778 | VASCUTEK LTD. |
NEWMAINS AVE. | RENFREWSHIRE,GLASGOW,SCOTLAND | PA4 9RR | |
| K955230 | VASCUTEK LTD. |
1300 EAST ANDERSON LN. | AUSTIN | TX | 78752 |
| K060142 | VASCUTEK LTD. |
NEWMAINS AVE. | RENFREWSHIRE, SCOTLAND | PA4 9RR | |
| K043552 | VASCUTEK LTD. |
6200 JACKSON RD. | ANN ARBOR | MI | 48103-9300 |
| K964959 | VASCUTEK LTD. |
1300 EAST ANDERSON LN. | AUSTIN | TX | 78752 |
| K051312 | VERYAN MEDICAL LIMITED |
1327 BLUEGRASS WAY | GAMBRILLS | MD | 21054 |
| K060741 | VERYAN MEDICAL LIMITED |
1327 BLUEGRASS WAY | GAMBRILLS | MD | 21054 |
| K013250 | W. L. GORE & ASSOCIATES, INC. |
3450 WEST KILTIE LN. | FLAGSTAFF | AZ | 86001 |
| K231505 | W. L. Gore & Associates, Inc. |
1505 N. Fourth Street | Flagstaff | AZ | 86004 |
| K093934 | W.L. GORE & ASSOCIATES |
3250 W. KILTIE LANE | FLAGSTAFF | AZ | 86001 |
| K955532 | W.L. GORE & ASSOCIATES,INC |
1505 NORTH FOURTH ST. | FLAGSTAFF | AZ | 86003-2200 |
| K991602 | W.L. GORE & ASSOCIATES,INC |
3450 WEST KILTIE LN. | FLAGSTAFF, | AZ | 86002 |
| K130215 | W.L. GORE & ASSOCIATES,INC |
1505 NORTH FOURTH ST. | FLAGSTAFF | AZ | 86003-3000 |
| K062161 | W.L. GORE & ASSOCIATES,INC |
1505 NORTH FOURTH ST. | FLAGSTAFF | AZ | 86003-3000 |
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