FDA 510(k) Applications for Medical Device:
Port & Catheter, Implanted, Subcutaneous, Intravascular
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K061424 | AESCULAP, INC. |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K101017 | ANGIODYNAMICS, INC. |
603 QUEENSBURY AVE. | QUEENSBURY | NY | 12804 |
| K081472 | ANGIODYNAMICS, INC. |
603 QUEENSBURY AVE. | QUEENSBURY | NY | 12804 |
| K190559 | AngioDynamics, Inc. |
26 Forest Street | Marlborough | MA | 01752 |
| K961583 | ARROW INTL., INC. |
1600 PROVIDENCE HIGHWAY | WALPOLE | MA | 02081 |
| K955819 | ARROW INTL., INC. |
1600 PROVIDENCE HIGHWAY | WALPOLE | MA | 02081 |
| K963684 | ARROW INTL., INC. |
1600 PROVIDENCE HIGHWAY | WALPOLE | MA | 02081 |
| K961652 | ARROW INTL., INC. |
1600 PROVIDENCE HIGHWAY | WALPOLE | MA | 02081 |
| K961615 | ARROW INTL., INC. |
1600 PROVIDENCE HIGHWAY | WALPOLE | MA | 02081 |
| K960572 | ARROW INTL., INC. |
1600 PROVIDENCE HIGHWAY | WALPOLE | MA | 02081 |
| K003006 | ARROW INTL., INC. |
2400 BERNVILLE RD. | READING | PA | 19605 |
| K130576 | B. BRAUN INTERVENTIONAL SYSTEMS INC. |
3100 W Lake St Ste 420 | Minneapolis | MN | 55416 |
| K952435 | B. BRAUN MEDICAL, INC. |
POSTFACH 110 CARL BRAUN STR 1 | MELSUNGEN | ||
| K962230 | B. BRAUN MEDICAL, INC. |
824 TWELFTH AVE. | BETHLEHEM | PA | 18018-0027 |
| K993024 | B. BRAUN OF AMERICA, INC. |
901 MARCON BLVD. | ALLENTOWN | PA | 18103 |
| K994111 | B. BRAUN/MCGAW |
901 MARCON BLVD. | ALLENTOWN | PA | 18103-9341 |
| K050310 | BARD ACCESS SYSTEMS, INC. |
5425 WEST AMELIA EARNHART DR. | SALT LAKE CITY | UT | 84116 |
| K974475 | BIOCONTROL TECHNOLOGY, INC. |
300 INDIAN SPRINGS RD. | INDIANA | PA | 15701 |
| K960350 | BIOCONTROL TECHNOLOGY, INC. |
300 INDIAN SPRINGS RD. | INDIANA | PA | 15701 |
| K964538 | BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. | NATICK | MA | 01760-1537 |
| K955587 | BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. | NATICK | MA | 01760-1537 |
| K982888 | BOSTON SCIENTIFIC CORP. |
One Boston Scientific Place | Natick | MA | 01760 |
| K032600 | BOSTON SCIENTIFIC CORP. |
10 GLENS FALLS TECHNICAL PARK | GLENS FALLS | NY | 12801-3864 |
| K032375 | BOSTON SCIENTIFIC CORP. |
10 GLENS FALLS TECHNICAL PARK | GLENS FALLS | NY | 12801-3864 |
| K030083 | BOSTON SCIENTIFIC CORP. |
10 GLENS FALLS TECHNICAL PARK | GLENS FALLS | NY | 12801-3864 |
| K031844 | BOSTON SCIENTIFIC CORP. |
10 GLENS FALLS TECHNICAL PARK | GLENS FALLS | NY | 12801-3864 |
| K032008 | BOSTON SCIENTIFIC CORP. |
One Boston Scientific Place | Natick | MA | 01760 |
| K983480 | BPOS, INC. |
NO.7 CORALWIND | ALISO VIEJO | CA | 92656 |
| K181446 | C.R. Bard, Inc. |
605 North 5600 West | Salt Lake City | UT | 84116 |
| K022983 | C.R. BARD, INC. |
5425 WEST AMELIA EARHART DR. | SALT LAKE CITY | UT | 84116 |
| K153359 | C.R. BARD, INC. |
605 NORTH 5600 WEST | SALT LAKE CITY | UT | 84116 |
| K964066 | C.R. BARD, INC. |
BARD ACCESS SYSTEMS | SALT LAKE CITY | UT | 84116 |
| K034065 | C.R. BARD, INC. |
5425 WEST AMELIA EARHART DR. | SALT LAKE CITY | UT | 84116 |
| K073423 | C.R. BARD, INC. |
605 N 5600 W | SALT LAKE CITY | UT | 84116 |
| K150514 | C.R. Bard, Inc. |
| Salt Lake City | UT | 84116 |
| K122899 | C.R. BARD, INC. |
605 NORTH 5600 WEST | SALT LAKE CITY | UT | 84116 |
| K090512 | C.R. BARD, INC. |
605 NORTH 5600 WEST | SALT LAKE CITY | UT | 84116 |
| K133335 | C.R. BARD, INC. |
605 N 5600 W | SALT LAKE CITY | UT | 84116 |
| K081311 | C.R. BARD, INC. |
605 NORTH 5600 WEST | SALT LAKE CITY | UT | 84116 |
| K063377 | C.R. BARD, INC. |
5425 WEST AMELIA EARHART DR. | SALT LAKE CITY | UT | 84116 |
| K060812 | C.R. BARD, INC. |
5425 WEST AMELIA EARHART DR. | SALT LAKE CITY | UT | 84116 |
| K072215 | C.R. BARD, INC. |
605 N 5600 W | SALT LAKE CITY | UT | 84116 |
| K072549 | C.R. BARD, INC. |
605 N 5600 W | SALT LAKE CITY | UT | 84116 |
| K032044 | C.R. BARD, INC. |
5425 WEST AMELIA EARHART DR. | SALT LAKE CITY | UT | 84116 |
| K991897 | CATHETER INNOVATIONS, INC. |
3598 WEST 1820 SOUTH | SALT LAKE CITY | UT | 84104 |
| K993860 | CATHETER INNOVATIONS, INC. |
3598 WEST 1820 SOUTH | SALT LAKE CITY | UT | 84104 |
| K000125 | CLINICAL PLASTIC PRODUCTS SA |
154 VIA LAMPARA | RANCHO SANTA MARGARITA | CA | 92688 |
| K030636 | CLINISURG VASCULAR PRODUCTS, LLC |
5454 AMESBURY DR., #2107 | DALLAS | TX | 75206 |
| K150733 | COOK INCORPORATED |
750 DANIELS WAY, P.O. BOX 489 | BLOOMINGTON | IN | 47402 |
| K140169 | COOK INCORPORATED |
750 DANIELS WAY | BLOOMINGTON | IN | 47404 |
| K081425 | COOK VASCULAR, INC. |
1186 MONTGOMERY LANE | VANDERGRIFT | PA | 15690 |
| K954258 | GERARD MEDICAL ENTERPRISES, INC. |
90 WORCESTER RD. | CHARLTON | MA | 01507 |
| K974533 | GERARD MEDICAL, INC. |
6 CITY DEPOT RD. | CHARLTON CITY | MA | 01508 |
| K081889 | GRANTADLER CORPORATION |
962 ALLEGRO LANE | APOLLO BEACH | FL | 33572 |
| K082126 | GRANTADLER CORPORATION |
962 ALLEGRO LANE | APOLLO BEACH | FL | 33572 |
| K043178 | GRANTADLER CORPORTATION |
1994 BANBURY AVENUE | YORKVILLE | IL | 60560 |
| K002770 | HDC CORP. |
2109 O'TOOLE AVE. | SAN JOSE | CA | 95131 |
| K994196 | HORIZON MEDICAL PRODUCTS, INC. |
1 HORIZON WAY | MANCHESTER | GA | 31816 |
| K010767 | HORIZON MEDICAL PRODUCTS, INC. |
1 HORIZON WAY | MANCHESTER | GA | 31816 |
| K033473 | HORIZON MEDICAL PRODUCTS, INC. |
1 HORIZON WAY | MANCHESTER | GA | 31816 |
| K032557 | HORIZON MEDICAL PRODUCTS, INC. |
1 HORIZON WAY | MANCHESTER | GA | 31816 |
| K010189 | HORIZON MEDICAL PRODUCTS, INC. |
1 HORIZON WAY | MANCHESTER | GA | 31816 |
| K032754 | HORIZON MEDICAL PRODUCTS, INC. |
1 HORIZON WAY | MANCHESTER | GA | 31816 |
| K962751 | IDEAS FOR MEDICINE, INC. |
12167 49TH ST. NORTH | CLEARWATER | FL | 34622 |
| K964559 | JIREH, INC. |
1212 RESTON AVE. | HERNDON | VA | 20170 |
| K974829 | KAWASUMI LABORATORIES CO., LTD. |
1575 EYE STREET, N.W. | WASHINGTON | DC | 20005 |
| K964117 | KAWASUMI LABORATORIES CO., LTD. |
1575 EYE STREET, N.W. | WASHINGTON | DC | 20005 |
| K022110 | KAWASUMI LABORATORIES, INC. |
1800 MASSACHUSETTS AVE N.W. | WASHINGTON | DC | 20036 |
| K031282 | LEMAITRE VASCULAR, INC. |
26 RAY AVE. | BURLINGTON | MA | 01803 |
| K021580 | LEMAITRE VASCULAR, INC. |
26 RAY AVE. | BURLINGTON | MA | 01803 |
| K982507 | MED INSTITUTE, INC. |
P.O. BOX 2402 | WEST LAFAYETTE | IN | 47906 |
| K970442 | MED INSTITUTE, INC. |
1400 CUMBERLAND AVE. | WEST LAFAYETTE | IN | 47906 |
| K971140 | MED INSTITUTE, INC. |
P.O. BOX 2402 | WEST LAFAYETTE | IN | 47906 |
| K973497 | MEDCARE MEDICAL GROUP, INC. |
234 OLD HOMESTEAD HWY. | EAST SWANZEY | NH | 03446 |
| K070003 | MEDCOMP |
1499 DELP DR. | HARLEYSVILLE | PA | 19438 |
| K153238 | Medcomp ( Medical Components) |
1499 Delp Drive | Harleysville | PA | 19438 |
| K110424 | MEDCOMP (MEDICAL COMPONENTS) |
1499 DELP DRIVE | HARLEYSVILLE | PA | 19438 |
| K132177 | MEDCOMP (MEDICAL COMPONENTS) |
1499 DELP DRIVE | HARLEYSVILLE | PA | 19438 |
| K130923 | MEDICAL COMPONENTS INC |
1499 DELP DRIVE | HARLEYSVILLE | PA | 19438 |
| K120281 | MEDICAL COMPONENTS INC |
1499 DELP DRIVE | HARLEYSVILLE | PA | 19438 |
| K151239 | NAVILYST MEDICAL, INC. |
26 FOREST STREET | MARLBOROUGH | MA | 01752 |
| K122767 | NAVILYST MEDICAL, INC. |
26 FOREST STREET | MARLBOROUGH | MA | 01752 |
| K131694 | NAVILYST MEDICAL, INC. |
26 FOREST STREET | MARLBOROUGH | MA | 01752 |
| K153228 | NAVILYST MEDICAL, INC. |
26 FOREST STREET | MARLBOROUGH | MA | 01752 |
| K971582 | NIPRO MEDICAL CORP. |
1384 COPPERFIELD COURT | LEXINGTON | KY | 40514-1268 |
| K111101 | NORFOLK MEDICAL |
7350 N. RIDGEWAY | SKOKIE | IL | 60076 |
| K102385 | NORFOLK MEDICAL PRODUCTS, INC. |
7350 NORTH RIDGEWAY | SKOKIE | IL | 60076 |
| K112713 | NORFOLK MEDICAL PRODUCTS, INC. |
7350 NORTH RIDGEWAY | SKOKIE | IL | 60076 |
| K122834 | Perouse Medical |
Route du Manoir | FRANCE | 60173 | |
| K072481 | PFM MEDICAL, INC |
2605 TEMPLE HEIGHTS DRIVE | OCEANSIDE | CA | 92056 |
| K122402 | PFM MEDICAL, INC |
1815 ASTON AVE, SUITE 106 | CARLSBAD | CA | 92008 |
| K073210 | PFM MEDICAL, INC |
2605 TEMPLE HEIGHTS DRIVE | OCEANSIDE | CA | 92056 |
| K071993 | PFM MEDICAL, INC |
2605 TEMPLE HEIGHTS DRIVE | OCEANSIDE | CA | 92056 |
| K091099 | PHS MEDICAL GMBH |
2360 JOHNSON RD. | SOUTHLAKE | TX | 76092 |
| K062414 | RITA MEDICAL SYSTEMS, INC. |
ONE HORIZON WAY | MANCHESTER | GA | 31816 |
| K050176 | RITA MEDICAL SYSTEMS, INC. |
1 HORIZON WAY | MANCHESTER | GA | 31816 |
| K992880 | SIMS DELTEC, INC. |
1265 GREY FOX RD. | ST. PAUL | MN | 55112 |
| K994216 | SIMS DELTEC, INC. |
1265 GREY FOX RD. | ST. PAUL | MN | 55112 |
| K955407 | SIMS DELTEC, INC. |
1265 GREY FOX RD. | ST. PAUL | MN | 55112 |
| K992697 | SIMS DELTEC, INC. |
1265 GREY FOX RD. | ST. PAUL | MN | 55112 |
| K962695 | SIMS DELTEC, INC. |
1265 GREY FOX RD. | ST. PAUL | MN | 55112 |
| K973862 | SIMS DELTEC, INC. |
1265 GREY FOX RD. | ST. PAUL | MN | 55112 |
| K961580 | SIMS DELTEC, INC. |
1265 GREY FOX RD. | ST. PAUL | MN | 55112 |
| K974471 | SIMS DELTEC, INC. |
1265 GREY FOX RD. | ST. PAUL | MN | 55112 |
| K010426 | SIMS DELTEC, INC. |
1265 GREY FOX RD. | ST. PAUL | MN | 55112 |
| K093414 | SMITHS MEDICAL ASD, INC. |
1265 GREY FOX ROAD | ST. PAUL | MN | 55112 |
| K033686 | SMITHS MEDICAL MD, INC. |
1265 GREY FOX ROAD | ST. PAUL | MN | 55112 |
| K060036 | SMITHS MEDICAL MD, INC. |
1265 GREY FOX RD. | ST. PAUL | MN | 55112 |
| K070116 | SMITHS MEDICAL MD, INC. |
1265 GREY FOX RD. | ST. PAUL | MN | 55112 |
| K072657 | SMITHS MEDICAL MD, INC. |
1265 GREY FOX RD. | ARDEN HILLS | MN | 55112 |
| K070911 | STD MED, INC. |
5 WHITCOMB AVENUE | AYER | MA | 01432 |
| K080645 | STD MED, INC. |
5 WHITCOMB AVENUE | AYER | MA | 01432 |
| K110407 | STEALTH THERAPEUTICS, INCORPORATED |
800 LEVANGER LANE | STOUGHTON | WI | 53589 |
| K141146 | STEALTH THERAPEUTICS, INCORPORATED |
800 LEVANGER LANE | STOUGHTON | WI | 53589 |
| K953529 | STRATO/INFUSAID, INC. |
1400 PROVIDENCE HIGHWAY | NORWOOD | MA | 02062 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
