FDA 510(k) Applications for Medical Device:
Catheter, Hemodialysis, Implanted
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K123943 | AMECO MEDICAL INDUSTRIES |
ARAZY GROUP | MONROE | CT | 03468 |
| K131814 | AMECO MEDICAL INDUSTRIES |
57 LAZY BROOK RD. | MONROE | CT | 03468 |
| K040402 | ANGIODYNAMICS, INC. |
603 QUEENSBURY AVE. | QUEENSBURY | NY | 12804 |
| K080400 | ANGIODYNAMICS, INC. |
603 QUEENSBURY AVE. | QUEENSBURY | NY | 12804 |
| K110936 | ANGIODYNAMICS, INC. |
14 PLAZA DRIVE | LATHAM | NY | 12110 |
| K101843 | ANGIODYNAMICS, INC. |
14 PLAZA DRIVE | LATHAM | NY | 12110 |
| K040260 | ARROW INT'L. |
2400 BERNVILLE RD. | READING | PA | 19605 |
| K040078 | ARROW INTERNATIONAL, INC. |
2400 BERNVILLE RD. | READING | PA | 19605 |
| K130192 | ARROW INTERNATIONAL, INC. |
2400 BERNVILLE RD. | READING | PA | 19605 |
| K040666 | ARROW INTERNATIONAL, INC. |
2400 BERNVILLE RD. | READING | PA | 19605 |
| K141051 | ARROW INTERNATIONAL, INC. |
2400 BERNVILLE RD. | READING | PA | 19605 |
| K022662 | ARROW INTL., INC. |
2400 BERNVILLE RD. | READING | PA | 19605 |
| K070572 | ASH ACCESS TECHNOLOGY, INC. |
3601 SAGAMORE PKWY N SUITE B | LAFAYETTE | IN | 47904 |
| K092597 | ASH ACCESS TECHNOLOGY, INC. |
3601 SAGAMORE PKWY N SUITE B | LAFAYETTE | IN | 47904 |
| K053589 | BARD ACCESS SYSTEMS, INC. |
5425 WEST AMELIA EARNHART DR. | SALT LAKE CITY | UT | 84116 |
| K211410 | Bard Peripheral Vascular, Inc |
1625 West 3rd Street | Tempe | AZ | 85281 |
| K982326 | BOSTON SCIENTIFIC CORP. |
One Boston Scientific Place | Natick | MA | 01760 |
| K012365 | BOSTON SCIENTIFIC CORP. |
One Boston Scientific Place | Natick | MA | 01760 |
| K040736 | BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. | NATICK | MA | 01760-1573 |
| K032712 | BOSTON SCIENTIFIC CORP. |
One Boston Scientific Place | Natick | MA | 01760 |
| K040492 | BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. | NATICK | MA | 01760-1537 |
| K012948 | BOSTON SCIENTIFIC/MEDI-TECH |
ONE BOSTON SCIENTIFIC PLACE | NATICK | MA | 01760-1537 |
| K203767 | C B Bard, Inc |
1625 W Third Street | Tempe | AZ | 85281 |
| K200627 | C R Bard, Inc |
1625 W Third Street | Tempe | AZ | 85281 |
| K190527 | C.R. Bard |
605 N 5600 W | Salt Lake City | UT | 84116 |
| K090528 | C.R. BARD, INC. |
605 N 5600 W | SALT LAKE CITY | UT | 84116 |
| K090101 | C.R. BARD, INC. |
605 N 5600 W | SALT LAKE CITY | UT | 84116 |
| K202150 | C.R. Bard, Inc. |
1625 W. Third Street | Tempe | AZ | 85281 |
| K203575 | C.R. Bard, Inc. |
1625 W. Third Street | Tempe | AZ | 85281 |
| K051748 | C.R. BARD, INC. |
5425 WEST AMELIA EARHART DR. | SALT LAKE CITY | UT | 84116 |
| K030020 | C.R. BARD, INC. |
5425 WEST AMELIA EARHART DR. | SALT LAKE CITY | UT | 84116 |
| K033294 | C.R. BARD, INC. |
5425 WEST AMELIA EARHART DR. | SALT LAKE CITY | UT | 84116 |
| K010567 | C.R. BARD, INC. |
5425 WEST AMELIA EARHART DR. | SALT LAKE CITY | UT | 84116 |
| K030277 | C.R. BARD, INC. |
5425 WEST AMELIA EARHART DR. | SALT LAKE CITY | UT | 84116 |
| K981994 | C.R. BARD, INC. |
5425 WEST AMELIA EARHART DR. | SALT LAKE CITY | UT | 84116 |
| K042672 | CARDIOMED SUPPLIES, INC. |
5 GORMLEY INDUSTRIAL AVENUE | GORMLEY, ONTARIO | L0H 1G0 | |
| K982333 | COOK, INC. |
925 SOUTH CURRY PIKE | BLOOMINGTON | IN | 47402 |
| K123196 | COVIDIEN |
15 HAMPSHIRE STREET | MANSFIELD | MA | 02048 |
| K111817 | COVIDIEN |
15 HAMPSHIRE STREET | MANSFIELD | MA | 02048 |
| K111372 | COVIDIEN |
15 HAMPSHIRE STREET | MANSFIELD | MA | 02048 |
| K092205 | COVIDIEN LP, FORMERLY REGISTERED AS KENDALL |
15 HAMPSHIRE ST. | MANSFIELD | MA | 02048 |
| K042016 | DATASCOPE CORP. |
1300 MACARTHUR BLVD | MAHWAH | NJ | 07430 |
| K030983 | DELTEC, INC. |
1265 GREY FOX RD. | ST. PAUL | MN | 55112 |
| K071202 | DERMAPORT, INC |
800 LEVANGER LANE | STOUGHTON | WI | 53589 |
| K091760 | DERMAPORT, INC |
25102 RYE CANYON LOOP | SANTA CLARITA | CA | 91355 |
| K010399 | DIATEK, INC. |
101 N. CHESTNUT ST. #300 | WINSTON-SALEM | NC | 27101 |
| K130851 | HEALTH LINE INTERNATIONAL CORPORATION |
803 N. 1250 W. | CENTERVILLE | UT | 84014 |
| K022905 | HORIZON MEDICAL PRODUCTS, INC. |
1 HORIZON WAY | MANCHESTER | GA | 31816 |
| K011916 | HORIZON MEDICAL PRODUCTS, INC. |
1 HORIZON WAY | MANCHESTER | GA | 31816 |
| K062671 | KENDALL |
15 HAMPSHIRE ST. | MANSFIELD | MA | 02048 |
| K051584 | KENDALL |
15 HAMPSHIRE ST. | MANSFIELD | MA | 02048 |
| K060972 | KENDALL |
15 HAMPSHIRE ST. | MANSFIELD | MA | 02048 |
| K033676 | KENDALL |
15 HAMPSHIRE ST. | MANSFIELD | MA | 02048 |
| K041914 | KENDALL |
15 HAMPSHIRE ST. | MANSFIELD | MA | 02048 |
| K043272 | KENDALL |
15 HAMPSHIRE ST. | MANSFIELD | MA | 02048 |
| K041006 | KENDALL |
15 HAMPSHIRE ST. | MANSFIELD | MA | 02048 |
| K140492 | MARVAO MEDICAL DEVICES, LTD. |
368 WEST MAIN STREET, SUITE 7 | NORTHBOROUGH | MA | 01532 |
| K121933 | MARVAO MEDICAL DEVICES, LTD. |
368 WEST MAIN STREET | NORTHBOROUGH | MA | 01532 |
| K143567 | MARVAO MEDICAL DEVICES, LTD. |
GMIT INNOVATION IN | GALWAY | ||
| K173805 | Marvao Medical Devices, Ltd. |
GMIT Innovation in Business Centre, Dublin Road | Galway | H91 DCH9 | |
| K133796 | MARVAO MEDICAL DEVICES, LTD. |
368 WEST MAIN STREET | NORTHBOROUGH | MA | 01532 |
| K171571 | Marvao Medical Devices, Ltd. |
GMIT Innovation in Business Centre, Dublin Road | Galway | ||
| K161026 | MARVAO MEDICAL DEVICES, LTD. |
GMIT INNOVATION IN BUSINESS CENTRE, DUBLIN RD | GALWAY | H91 DCH9 | |
| K043292 | MED-CONDUIT, INC. |
18 DERBY LANE | TYNGSBORO | MA | 01879 |
| K062901 | MED-CONDUIT, INC. |
18 DERBY LANE | TYNGSBORO | MA | 01879 |
| K020936 | MEDCOMP |
1499 DELP DR. | HARLEYSVILLE | PA | 19438 |
| K030502 | MEDCOMP |
1499 DELP DR. | HARLEYSVILLE | PA | 19438 |
| K020315 | MEDCOMP |
1499 DELP DR. | HARLEYSVILLE | PA | 19438 |
| K021759 | MEDCOMP |
1499 DELP DR. | HARLEYSVILLE | PA | 19438 |
| K040328 | MEDCOMP |
1499 DELP DR. | HARLEYSVILLE | PA | 19438 |
| K040992 | MEDCOMP |
1499 DELP DR. | HARLEYSVILLE | PA | 19438 |
| K972207 | MEDCOMP |
1499 DELP DR. | HARLEYSVILLE | PA | 19438 |
| K020465 | MEDCOMP |
1499 DELP DR. | HARLEYSVILLE | PA | 19438 |
| K010306 | MEDCOMP |
1499 DELP DR. | HARLEYSVILLE | PA | 19438 |
| K022678 | MEDCOMP |
1499 DELP DR. | HARLEYSVILLE | PA | 19438 |
| K051280 | MEDCOMP |
1499 DELP DR. | HARLEYSVILLE | PA | 19438 |
| K040318 | MEDCOMP |
1499 DELP DR. | HARLEYSVILLE | PA | 19438 |
| K130889 | MEDCOMP |
1499 DELP DR. | HARLEYSVILLE | PA | 19438 |
| K171618 | Medcomp (DBA Medical Components, Inc.) |
1499 Delp Drive | Harleysville | PA | 19438 |
| K113487 | MEDICAL COMPONENTS INC |
1499 DELP DRIVE | HARLEYSVILLE | PA | 19438 |
| K111651 | MEDICAL COMPONENTS INC |
1499 DELP DRIVE | HARLEYSVILLE | PA | 19438 |
| K121848 | MEDICAL COMPONENTS INC |
1499 DELP DRIVE | HARLEYSVILLE | PA | 19438 |
| K202176 | Medical Components Inc. (Dba Medcomp) |
1499 Delp Drive | Harleysville | PA | 19438 |
| K210461 | Medical Components Inc. (Medcomp) |
1499 Delp Drive | Harleysville | PA | 19438 |
| K994105 | MEDICAL COMPONENTS, INC. |
1499 DELP DR. | HARLEYSVILLE | PA | 19438 |
| K012562 | MEDICAL COMPONENTS, INC. |
1499 DELP DR. | HARLEYSVILLE | PA | 19438 |
| K971925 | MEDICAL COMPONENTS, INC. |
1499 DELP DR. | HARLEYSVILLE | PA | 19438 |
| K981125 | MEDICAL COMPONENTS, INC. |
1499 DELP DR. | HARLEYSVILLE | PA | 19438 |
| K003207 | MEDICAL COMPONENTS, INC. |
1499 DELP DR. | HARLEYSVILLE | PA | 19438 |
| K173667 | Medical Components, Inc. (Dba Medcomp) |
1499 Delp Drive | Harleysville | PA | 19438 |
| K141363 | MERIT MEDICAL SYSTEMS, INC. |
1600 WEST MERIT PKWY. | SOUTH JORDAN | UT | 84095 |
| K151967 | Merit Medical Systems, Inc. |
1600 West Merit Parkway | South Jordan | UT | 84095 |
| K090148 | MERIT MEDICAL SYSTEMS, INC. |
1600 WEST MERIT PKWY. | SOUTH JORDAN | UT | 84095 |
| K131260 | NAVILYST MEDICAL, INC. |
26 FOREST STREET | MARLBOROUGH | MA | 01752 |
| K072499 | NOVOSCI, INC. |
2828 NORTH CRESCENT RIDGE DR. | THE WOODLANDS | TX | 77381 |
| K140884 | PHASE ONE MEDICAL |
55 NORTHERN BLVD SUITE 200 | GREAT NECK | NY | 11021 |
| K182443 | Pristine Access Technologies Ltd. |
21 (B) Habarzel Street | Tel Aviv | 6971029 | |
| K100169 | R4 VASCULAR, INC. |
7550 MERIDIAN CIR. N | MAPLE GROVE | MN | 55369 |
| K091506 | R4 VASCULAR, INC. |
7550 MERIDIAN CIR. N | MAPLE GROVE | MN | 55369 |
| K071422 | REX MEDICAL |
55 Northern Blvd. | Great Neck | NY | 11021 |
| K023847 | REX MEDICAL |
55 Northern Blvd. | Great Neck | NY | 11021 |
| K102043 | REX MEDICAL |
55 Northern Blvd. | Great Neck | NY | 11021 |
| K981365 | SHERWOOD MEDICAL CO. |
3303 MONTE VILLA PKWY. | BOTHELL | WA | 98021 |
| K063431 | SPIRE BIOMEDICAL INC |
ONE PATRIOTS PARK | BEDFORD | MA | 01730 |
| K063441 | SPIRE BIOMEDICAL INC |
ONE PATRIOTS PARK | BEDFORD | MA | 01730 |
| K021212 | SPIRE BIOMEDICAL INC |
ONE PATRIOTS PARK | BEDFORD | MA | 01730 |
| K041559 | SPIRE BIOMEDICAL INC |
ONE PATRIOTS PARK | BEDFORD | MA | 01730-2396 |
| K040509 | SPIRE BIOMEDICAL INC |
ONE PATRIOTS PARK | BEDFORD | MA | 01730 |
| K073093 | SPIRE BIOMEDICAL INC |
ONE PATRIOTS PARK | BEDFORD | MA | 01730 |
| K073092 | SPIRE BIOMEDICAL INC |
ONE PATRIOTS PARK | BEDFORD | MA | 01730 |
| K022000 | SPIRE BIOMEDICAL INC |
ONE PATRIOTS PARK | BEDFORD | MA | 01730 |
| K013160 | SPIRE BIOMEDICAL INC |
ONE PATRIOTS PARK | BEDFORD | MA | 01730 |
| K060155 | SPIRE BIOMEDICAL, INC. |
ONE PATRIOTS PARK | BEDFORD | MA | 01730-2396 |
| K042858 | SPIRE BIOMEDICAL, INC. |
ONE PATRIOTS PARK | BEDFORD | MA | 01730-2396 |
| K032061 | SPIRE BIOMEDICAL, INC. |
ONE PATRIOTS PARK | BEDFORD | MA | 01730-2396 |
| K060288 | SPIRE BIOMEDICAL, INC. |
ONE PATRIOTS PARK | BEDFORD | MA | 01730-2396 |
| K102238 | Teleflex Medical, Inc. |
2400 BERNVILLE ROAD | READING | PA | 19605 |
| K111117 | Teleflex Medical, Inc. |
2400 BERNVILLE ROAD | READING | PA | 19605 |
| K111900 | Teleflex Medical, Inc. |
2400 BERNVILLE ROAD | READING | PA | 19605 |
| K002901 | THE KENDALL COMPANY |
15 HAMPSHIRE ST. | MANSFIELD | MA | 02048 |
| K002902 | THE KENDALL COMPANY |
15 HAMPSHIRE ST. | MANSFIELD | MA | 02048 |
| K023023 | VASCA, INC. |
3 HIGHWOOD DR. | TEWKSBURY | MA | 01876 |
| K001633 | VASCA, INC. |
3 HIGHWOOD DR. | TEWKSBURY | MA | 01876 |
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