FDA 510(k) Applications for Medical Device:
Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K213550 Access Vascular Inc 175 Middlesex Trunpike
Bedford MA 01730
K172885 Access Vascular, Inc 175 Middlesex Turnpike
Bedford MA 01730
K193015 Access Vascular, Inc 175 Middlesex Turnpike
Bedford MA 01730
K152819 AMECO MEDICAL INDUSTRIES INDUSTRIAL AREA B4-PLOT
10TH OF RAMADAN CITY
K060887 ANGIODYNAMICS, INC. 603 QUEENSBURY AVE.
QUEENSBURY NY 12804
K072196 ANGIODYNAMICS, INC. 603 QUEENSBURY AVE.
QUEENSBURY NY 12804
K030415 ANGIODYNAMICS, INC. 603 QUEENSBURY AVE.
QUEENSBURY NY 12804
K031626 ANGIODYNAMICS, INC. 603 QUEENSBURY AVE.
QUEENSBURY NY 12804
K040446 ANGIODYNAMICS, INC. 603 QUEENSBURY AVE.
QUEENSBURY NY 12804
K041420 ANGIODYNAMICS, INC. 603 QUEENSBURY AVE.
QUEENSBURY NY 12804
K070613 ANGIODYNAMICS, INC. 603 QUEENSBURY AVE.
QUEENSBURY NY 12804
K070615 ANGIODYNAMICS, INC. 603 QUEENSBURY AVE.
QUEENSBURY NY 12804
K142889 ANGIODYNAMICS, INC. 26 FOREST STREET
MARLBOROUGH MA 01751
K093406 ANGIODYNAMICS, INC. 603 QUEENSBURY AVE.
QUEENSBURY NY 12804
K061289 ARROW INTERNATIONAL, INC. 2400 BERNVILLE RD.
READING PA 19605
K113277 ARROW INTERNATIONAL, INC. 2400 BERNVILLE RD.
READING PA 19605
K130876 ARROW INTERNATIONAL, INC. 2400 BERNVILLE RD.
READING PA 19605
K073451 ARROW INTERNATIONAL, INC. 2400 BERNVILLE RD.
READING PA 19605
K080604 ARROW INTERNATIONAL, INC. 2400 BERNVILLE RD.
READING PA 19605
K160925 ARROW INTERNATIONAL, INC. (A SUBSIDIARY OF TELEFLEX, INC.) 2400 BERNVILLE RD.
READING PA 19605
K153487 ARROW INTERNATIONAL, INC. (Subsidiary of Teleflex Inc.) 2400 BERNVILLE ROAD
READING PA 19605
K161765 ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, 2400 BERNVILLE ROAD
READING PA 19605
K123759 ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, 2400 BERNVILLE ROAD
READING PA 19605
K153423 ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.) 2400 BERNVILLE ROAD
READING PA 19605
K220363 Arrow International, LLC (a subsidiary of Teleflex, Inc.) 3015 Carrington Mill Blvd
Morrisville NC 27560
K121501 ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) 2400 BERNVILLE RD.
READING PA 19605
K121941 ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) 2400 BERNVILLE RD.
READING PA 19605
K112896 ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) 2400 BERNVILLE RD.
READING PA 19605
K122545 ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) 2400 BERNVILLE RD.
READING PA 19605
K100635 ARROW INTL., INC. 2400 BERNVILLE RD.
READING PA 19605
K963257 ARROW INTL., INC. P.O. BOX 12888
READING PA 19612
K042126 ARROW INTL., INC. 2400 BERNVILLE ROAD
READING PA 19612
K970926 B. BRAUN MEDICAL, INC. 824 TWELFTH AVE.
BETHLEHEM PA 18018
K971999 B. BRAUN MEDICAL, INC. 824 TWELFTH AVE.
BETHLEHEM PA 18018-0027
K964929 B. BRAUN MEDICAL, INC. 824 12TH AVE.
BETHLEHEM PA 18018
K971085 B. BRAUN MEDICAL, INC. 824 TWELFTH AVE.
BETHLEHEM PA 18018
K210264 Bard Access Systems, Inc. 605 North 5600 West
Salt Lake City UT 84116
K051672 BARD ACCESS SYSTEMS, INC. 5425 WEST AMELIA EARNHART DR.
SALT LAKE CITY UT 84116
K053501 BARD ACCESS SYSTEMS, INC. 5425 WEST AMELIA EARNHART DR.
SALT LAKE CITY UT 84116
K222232 Bard Access Systems, Inc. 605 North 5600 West
Salt Lake City UT 84116
K091670 BECTON DICKINSON & CO. 9450 SOUTH STATE STREET
SANDY UT 84070
K042491 BECTON DICKINSON & CO. 9450 SOUTH STATE STREET
SANDY UT 84070
K051194 BECTON DICKINSON & CO. 9450 SOUTH STATE STREET
SANDY UT 84070
K192246 Biowy Corporation 27031/27002 Vista Terrace
Lake Forest CA 92630
K173956 Biowy Corporation 27031/27002 Vista Terrace
Lake Forest CA 92630
K962300 BMW MEDICAL, INC. 5945 SOUTH 350 WEST
MURRAY UT 84107
K963215 BMW MEDICAL, INC. 3598 WEST 1820 SOUTH
SALT LAKE CITY UT 84104-4959
K963806 BMW MEDICAL, INC. 3598 WEST 1820 SOUTH
SALT LAKE CITY UT 84104-4959
K963097 BMW MEDICAL, INC. 3598 WEST 1820 SOUTH
SALT LAKE CITY UT 84104-4959
K003839 BOSTON SCIENTIFIC CORP. One Boston Scientific Place
Natick MA 01760
K070002 BOSTONSCIENTIFIC 100 BOSTON SCIENTIFIC WAY
MARLBOROUGH MA 01752
K172511 C.R. Bard, Inc 605 North 5600 West
Salt Lake City UT 84116
K162441 C.R. BARD, INC 605 NORTH 5600 WEST
SALT LAKE CITY UT 84116
K151985 C.R. Bard, Inc 605 North 5600 West
Salt Lake City UT 84116
K180548 C.R. Bard, Inc (Bard has joined BD) 605 North 5600 West
Salt Lake City UT 84116
K070996 C.R. BARD, INC. 5425 WEST AMELIA EARHART DR.
SALT LAKE CITY UT 84116
K050931 C.R. BARD, INC. 5425 WEST AMELIA EARHART DR.
SALT LAKE CITY UT 84116
K051417 C.R. BARD, INC. 5425 WEST AMELIA EARHART DR.
SALT LAKE CITY UT 84116
K043502 C.R. BARD, INC. 5425 WEST AMELIA EARHART DR.
SALT LAKE CITY UT 84116
K093927 C.R. BARD, INC. 605 NORTH 5600 WEST
SALT LAKE CITY UT 84116
K023374 C.R. BARD, INC. 5425 WEST AMELIA EARHART DR.
SALT LAKE CITY UT 84116
K201452 C.R. Bard, Inc. 605 North 5600 West
Salt Lake City UT 84116
K034020 C.R. BARD, INC. 5425 WEST AMELIA EARHART DR.
SALT LAKE CITY UT 84116
K001901 C.R. BARD, INC. 5425 WEST AMELIA EARHART DR.
SALT LAKE CITY UT 84116
K034019 C.R. BARD, INC. 5425 WEST AMELIA EARHART DR.
SALT LAKE CITY UT 84116
K031129 C.R. BARD, INC. 5425 WEST AMELIA EARHART DR.
SALT LAKE CITY UT 84116
K012902 C.R. BARD, INC. 5425 WEST AMELIA EARHART DR.
SALT LAKE CITY UT 84116
K063848 C.R. BARD, INC. 5425 WEST AMELIA EARHART DR.
SALT LAKE CITY UT 84116
K061179 C.R. BARD, INC. 5425 WEST AMELIA EARHART DR.
SALT LAKE CITY UT 84116
K050185 C.R. BARD, INC. 5425 WEST AMELIA EARHART DR.
SALT LAKE CITY UT 84116
K033389 C.R. BARD, INC. 5425 WEST AMELIA EARHART DR.
SALT LAKE CITY UT 84116
K162443 C.R. BARD, INC. 605 NORTH 5600 WEST
SALT LAKE CITY UT 84116
K072230 C.R. BARD, INC. 5425 WEST AMELIA EARHART DR.
SALT LAKE CITY UT 84116
K102159 C.R. BARD, INC. 605 NORTH 5600 WEST
SALT LAKE CITY UT 84116
K051991 C.R. BARD, INC. 5425 WEST AMELIA EARHART DR.
SALT LAKE CITY UT 84116
K112744 C.R. BARD, INC. 605 NORTH 5600 WEST
SALT LAKE CITY UT 84116
K172397 C.R. Bard, Inc. 605 North 5600 West
Salt Lake City UT 84116
K091324 C.R. BARD, INC. 605 NORTH 5600 WEST
SALT LAKE CITY UT 84116
K180560 C.R. Bard, Inc. 605 North 5600 West
Salt Lake City UT 84116
K063240 C.R. BARD, INC. 5425 WEST AMELIA EARHART DR.
SALT LAKE CITY UT 84116
K030255 C.R. BARD, INC. 5425 WEST AMELIA EARHART DR.
SALT LAKE CITY UT 84116
K113808 C.R. BARD, INC. 605 NORTH 5600 WEST
SALT LAKE CITY UT 84116
K140345 C.R. BARD, INC. 605 NORTH 5600 WEST
SALT LAKE CITY UT 84116
K041088 C.R. BARD, INC. 5425 WEST AMELIA EARHART DR.
SALT LAKE CITY UT 84116
K142267 C.R.Bard, Inc. 605 North 5600 West
Salt Lake City UT 84116
K010349 CATHETER INNOVATIONS, INC. 3598 WEST 1820 SOUTH
SALT LAKE CITY UT 84104
K003642 CATHETER INNOVATIONS, INC. 3598 WEST 1820 SOUTH
SALT LAKE CITY UT 84104
K021704 CATHETER INNOVATIONS, INC. 3598 WEST 1820 SOUTH
SALT LAKE CITY UT 84104
K141818 COOK CORPORATED 60 DANIELS WAY
BLOOMINGTON IN 47404
K171994 Cook Incorporated 750 Daniels Way
Bloomington IN 47404
K161496 COOK INCORPORATED 750 DANIELS WAY
BLOOMINGTON IN 47404
K132885 COOK INCORPORATED 750 DANIELS WAY
BLOOMINGTON IN 47404
K133634 COOK, INC. 750 DANIELS WAY
Blmgtn IN 47404
K041849 COOK, INC. 750 DANIELS WAY
BLOOMINGTON IN 47402
K072625 COOK, INC. 750 DANIELS WAY
BLOOMINGTON IN 47402
K111244 COOK, INC. 750 DANIELS WAY
BLOOMINGTON IN 47402
K132334 COOK, INC. 750 DANIELS WAY
Blmgtn IN 47404
K132567 COVIDIEN 15 HAMPSHIRE STREET
MANSFIELD MA 02048
K072518 CRS MEDICAL DIAGNOSTICS INC. PO BOX 7007
DEERFIELD IL 60015
K050889 CRS MEDICAL DIAGNOSTICS INC. 662 CAPITOL DRIVE
PEWAUKEE WI 53072
K961155 DOUGLAS MEDICAL PRODUCTS CORP. 1840 INDUSTRIAL DR., SUITE 200
LIBERTYVILLE IL 60048
K993614 FAS MEDICAL LTD. PO BOX 218
INDIAN HILLS CO 80454
K012641 FAS MEDICAL LTD. PO BOX 219
INDIAN HILLS CO
K063363 FLEXICATH LTD. 20 HATAAS STR.
KFAR SABA 44425
K091488 FOOTPRINT MEDICAL 1203 CAMDEN ST.
SAN ANTONIO TX 78215
K093252 FOOTPRINT MEDICAL INC. 1203 CAMDEN STREET
SAN ANTONIO TX 78215
K130507 FOOTPRINT MEDICAL INC. 12727 CIMARRON PATH
SAN ANTONIO TX 78249
K972555 GERARD MEDICAL, INC. 6 CITY DEPOT RD.
CHARLTON CITY MA 01508
K953300 HDC CORP. 2109 O'TOOLE AVE.
SAN JOSE CA 95131
K071875 HDC CORP. 628 GIBRALTAR CT.
MILPITAS CA 95035
K101329 HEALTH LINE INTERNATIONAL CORPORATION 803 N. 1250 W.
CENTERVILLE UT 84014
K130034 HEALTH LINE INTERNATIONAL CORPORATION 803 N. 1250 W.
CENTERVILLE UT 84014
K031718 HORIZON MEDICAL PRODUCTS, INC. 1 HORIZON WAY
MANCHESTER GA 31816
K092306 INTERRAD MEDICAL, INC. 555 13TH STREET NW
WASHINGTON DC 20004
K180546 Jet Medical, Inc. 97 Main Street
Schwenksville PA 19473
K964556 JOHNSON & JOHNSON MEDICAL, INC. 1350 WILLOW RD.
MENLO PARK CA 94025
K042461 KENDALL 15 HAMPSHIRE ST.
MANSFIELD MA 02048
K970434 KLEIN-BAKER MEDICAL, INC. 12001 NETWORK, SUITE 110
SAN ANTONIO TX 78249
K153469 L&Z US, INC. 6 HORIZON ROAD, #2301
FORT LEE NJ 07024
K170486 L&Z US, Inc. 6 Horizon Road
Fort Lee NJ 07024
K172039 L&Z US, Inc. 6 Horizon Road
Fort Lee NJ 07024
K232571 L&Z US, Inc. 49 Walnut Street
Norwood NJ 07648
K232594 L&Z US, Inc. 49 Walnut Street
Norwood NJ 07648
K061240 LUCENT MEDICAL SYSTEMS 811 KIRKLAND AVENUE; SUITE 100
KIRKLAND WA 98033
K980090 LUTHER MEDICAL PRODUCTS, INC. 530 KINGS RD.
NEWPORT BEACH CA 92663-5710
K050542 MARIAN MEDICAL, INC. 319 WESTPORT DR.
LOUISVILLE KY 40207
K110627 MARVAO MEDICAL DEVICES, LTD. 368 WEST MAIN STREET
NORTHBORO MA 01532
K962849 MEDCARE MEDICAL GROUP, INC. 234 OLD HOMESTEAD HWY.
EAST SWANZEY NH 03446
K061986 MEDCOMP 1499 DELP DR.
HARLEYSVILLE PA 19438
K091466 MEDCOMP 1499 DELP DR.
HARLEYSVILLE PA 19438
K102966 MEDCOMP 1499 DELP DR.
HARLEYSVILLE PA 19438
K030270 MEDCOMP 1499 DELP DR.
HARLEYSVILLE PA 19438
K003110 MEDCOMP 1499 DELP DR.
HARLEYSVILLE PA 19438
K053345 MEDCOMP 1499 DELP DR.
HARLEYSVILLE PA 19438
K091953 MEDCOMP 1499 DELP DR.
HARLEYSVILLE PA 19438
K081904 MEDCOMP 1499 DELP DR.
HARLEYSVILLE PA 19438
K092347 MEDCOMP 1499 DELP DR.
HARLEYSVILLE PA 19438
K072509 MEDCOMP 1499 DELP DR.
HARLEYSVILLE PA 19438
K091586 MEDCOMP 1499 DELP DR.
HARLEYSVILLE PA 19438
K171931 Medcomp (Medical Components, Inc.) 1499 Delp Dr.
Harleysville PA 19438
K140799 MEDCOMP (MEDICAL COMPONENTS, INC.) 25 FOREST DRIVE
MARLBOROUGH MA 01752
K141151 MEDCOMP (MEDICAL COMPONENTS, INC.) 1499 DELP DR.
HARLEYSVILLE PA 19438
K143238 MEDCOMP (MEDICAL COMPONENTS) 1499 Delp Drive
Harleysville PA 19438
K130897 MEDCOMP (MEDICAL COMPONENTS) 1499 DELP DRIVE
HARLEYSVILLE PA 19438
K093309 MEDCOMP (MEDICAL COMPONENTS) 1499 DELP DRIVE
HARLEYSVILLE PA 19438
K120980 MEDICAL COMPONENTS INC 1499 DELP DRIVE
HARLEYSVILLE PA 19438
K120981 MEDICAL COMPONENTS INC 1499 DELP DRIVE
HARLEYSVILLE PA 19438
K123617 MEDICAL COMPONENTS INC 1499 DELP DRIVE
HARLEYSVILLE PA 19438
K131687 MEDICAL COMPONENTS INC 1499 DELP DRIVE
HARLEYSVILLE PA 19438
K121094 MEDICAL COMPONENTS INC 1499 DELP DRIVE
HARLEYSVILLE PA 19438
K141633 MEDICAL COMPONENTS INC 1499 DELP DRIVE
HARLEYSVILLE PA 19438
K122423 MEDICAL COMPONENTS INC 1499 DELP DRIVE
HARLEYSVILLE PA 19438
K170934 Medical Components, Inc (Dba Medcomp_ 1499 Delp Drive
Harleysville PA 19438
K983412 MEDICAL COMPONENTS, INC. 1499 DELP DR.
HARLEYSVILLE PA 19438
K003682 MEDICAL COMPONENTS, INC. 1499 DELP DR.
HARLEYSVILLE PA 19438
K180567 Medical Components, Inc. (dba Medcomp) 1499 Delp Drive
Harleysville PA 19438
K961336 MEDTRONIC PS MEDICAL 125 CREMONA DR.
GOLETA CA 93117-5500
K964447 MENLO CARE, INC. 1350 WILLOW RD.
MENLO PARK CA 94025-1516
K122882 NAVILYST MEDICAL, INC. 26 FOREST STREET
MARLBOROUGH MA 01752
K101326 NAVILYST MEDICAL, INC. 26 FOREST STREET
MARLBOROUGH MA 01752
K091261 NAVILYST MEDICAL, INC. 26 FOREST STREET
MARLBOROUGH MA 01752
K093366 NAVILYST MEDICAL, INC. 26 FOREST STREET
MARLBOROUGH MA 01752
K121089 NAVILYST MEDICAL, INC. 26 FOREST STREET
MARLBOROUGH MA 01752
K133264 NAVILYST MEDICAL, INC. 26 FOREST STREET
MARLBOROUGH MA 01752
K150448 NAVILYST MEDICAL, INC. 26 FOREST STREET
MARLBOROUGH MA 01752
K131942 NAVILYST MEDICAL, INC. 26 FOREST STREET
MARLBOROUGH MA 01752
K140266 NAVILYST MEDICAL, INC. 26 FOREST STREET
MARLBOROUGH MA 01752
K131038 NAVILYST MEDICAL, INC. 26 FOREST STREET
MARLBOROUGH MA 01752
K121990 NAVILYST MEDICAL, INC. 26 FOREST STREET
MARLBOROUGH MA 01752
K142616 NAVILYST MEDICAL, INC. 26 FOREST STREET
MARLBOROUGH MA 01752
K163452 Navilyst Medical, Inc. 26 Forest Street
Marlborough MA 01752
K111906 NAVILYST MEDICAL, INC. 26 FOREST STREET
MARLBOROUGH MA 01752
K152409 NAVILYST MEDICAL, INC. 26 FOREST STREET
MARLBOROUGH MA 01752
K150527 NAVILYST MEDICAL, INC. 26 FOREST STREET
MARLBOROUGH MA 01752
K973057 NAVION BIOMEDICAL CORP. 312 TOSCA DR.
STOUGHTON MA 02072
K030400 NEOSCI MEDICAL, INC. 148 S. 1200 E.
SALT LAKE CITY UT 84102
K152261 NOSTIX LLC 5541 CENTRAL AVE, SUITE 170
BOULDER CO 80301
K072391 PFM MEDICAL, INC 2605 TEMPLE HEIGHTS DRIVE
OCEANSIDE CA 92056
K083873 PFM MEDICAL, INC 2605 TEMPLE HEIGHTS DRIVE
OCEANSIDE CA 92056
K110914 PFM MEDICAL, INC 1815 ASTON AVE
CARLSBAD CA 92008
K200037 Piccolo Medical, Inc 101 Mississippi St
San Fransico CA 94107
K181904 Piper Access LLC 3981 South 700 East Suite 15
Salt Lake City UT 84107
K992424 PLASTIMED LABORATOIRE PHARMACEUTIQUE 95321 SAINT-LUE-LA-FORET
CEDEX
K960055 PUDENZ-SCHULTE MEDICAL RESEARCH CORP. UNIV BUSINESS CTR.
GOLETA CA 93117
K092040 R4 VASCULAR, INC. 7550 MERIDIAN CIR. N
MAPLE GROVE MN 55369
K071361 R4 VASCULAR, INC. 1246 UNIVERSITY AVENUE WEST
ST. PAUL MN 55104
K083763 R4 VASCULAR, INC. 7550 MERIDIAN CIR. N
MAPLE GROVE MN 55369
K062579 RITA MEDICAL SYSTEMS, INC. ONE HORIZON WAY
MANCHESTER GA 31816
K051102 RITA MEDICAL SYSTEMS, INC. 1 HORIZON WAY
MANCHESTER GA 31816
K093775 ROMEDEX INTERNATIONAL SRL 175 COLORADO AVENUE
PALO ALTO CA 94303
K141634 ROMEDEX INTERNATIONAL SRL 625 CLAYTON STR
SAN FRANCISCO CA 94117
K113225 SEMPRUS BIOSCIENCES ONE KENDALL SQUARE
CAMBRIDGE MA 02139
K970269 SIMS DELTEC, INC. 1265 GREY FOX RD.
ST. PAUL MN 55112
K954720 STRATO/INFUSAID, INC. 1400 PROVIDENCE HIGHWAY
NORWOOD MA 02062
K113043 SUMMIT MEDICAL PRODUCTS, INC 2480 S Main St Ste 212
Salt Lake Cty UT 84115
K061936 THE KENDALL COMPANY 15 HAMPSHIRE ST.
MANSFIELD MA 02048-1108
K961856 UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE.
NORWALK CT 06856
K001874 UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST
MIDVALE UT 84047-1048
K082481 VASONOVA INC. 1368 BORDEAUX DR., SUITE 100
SUNNYVALE CA 94089
K083920 VASONOVA INC. 1368 BORDEAUX DR., SUITE 100
SUNNYVALE CA 94089
K091924 VASONOVA INC. 1368 BORDEAUX DR., SUITE 100
SUNNYVALE CA 94089
K954638 VYGON CORP. 1129 BLOOMFIELD AVE.
WEST CALDWELL NJ 07006
K062425 VYGON CORP. 2495 GENERAL ARMISTEAD AVE
NORRISTOWN PA 19403
K041468 VYGON CORP. 2495 GENERAL ARMISTEAD AVE
NORRISTOWN PA 19403
K993052 VYGON CORP. 1129 BLOOMFIELD AVE.
WEST CALDWELL NJ 07006
K983544 VYGON CORP. 1129 BLOOMFIELD AVE.
WEST CALDWELL NJ 07006
K993442 VYGON CORP. 1129 BLOOMFIELD AVE.
WEST CALDWELL NJ 07006
K051690 VYGON CORP. 2495 GENERAL ARMISTEAD AVE
NORRISTOWN PA 19403
K954302 VYGON CORP. 304 VERONA AVE.
ELIZABETH NJ 07208
K052475 VYGON US LLC 2495 GENERAL ARMSTEAD AVE.
NORRISTOWN PA 19403
K172899 Vygon USA 2750 Morris Rd
Lansdale PA 19460




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