FDA 510(k) Applications for Medical Device:
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K113132 | COEUR, INC. |
100 PHYSICIANS WAY | LEBANON | TN | 37090 |
| K073260 | DEVICE PARTNERS INTERNATIONAL |
4305 ENTERPRISE DRIVE | WINSTON-SALEM | NC | 27106 |
| K113667 | EDWARDS LIFESCIENCES, LLC. |
12050 Lone Peak Pkwy | Draper | UT | 84020 |
| K060759 | ELCAM MEDICAL ACAL |
KIBUTZ BARAM | D.N. MEROM HAGALIL | 13860 | |
| K152528 | GALT MEDICAL CORP. |
2220 MERRITT DR. | GARLAND | TX | 75041 |
| K030077 | GISH BIOMEDICAL, INC. |
11874 SOUTH EVELYN CIRCLE | HOUSTON | TX | 77071 |
| K991102 | GUIDANT CORP. |
26531 YNEZ RD. | TEMECULA | CA | 92591-4630 |
| K031398 | GUIDANT CORP. |
4100 Hamline Avenue North | St. Paul | MN | 55112-5798 |
| K021282 | GUIDANT CORP. |
4100 HAMLINE AVE., NORTH | ST. PAUL | MN | 55112-5798 |
| K031688 | GUIDANT CORPORATION |
4100 HAMLINE AVE NORTH | ST PAUL | MN | 55112-5798 |
| K131124 | JILIN CORONADO MEDICAL LTD. |
9 South-Western Ring Road | Jilin | 132016 | |
| K963749 | MAXXIM MEDICAL |
100 EAST 15TH ST. | FORT WORTH | TX | 76102 |
| K954284 | MEDI-PLAST INTL., INC. |
55 NORTHERN BLVD. | GREAT NECK | NY | 11021 |
| K972654 | MEDICAL SPECIALTIES INTL., INC. |
615 JASMINE AVENUE N. | TARPON SPRINGS | FL | 34689 |
| K120069 | MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE | MUNDELEIN | IL | 60060 |
| K953564 | MEDTRONIC CARDIAC SURGERY, MEDTRONIC, INC. |
4633 EAST LA PALMA AVE. | ANAHEIM | CA | 92807 |
| K123448 | MEDTRONIC INC. |
7611 NORTHLAND DRIVE | MINNEAPOLIS | MN | 55428 |
| K122811 | MEDTRONIC INC. |
7611 NORTHLAND DRIVE | MINNEAPOLIS | MN | 55428 |
| K113845 | MEDTRONIC INC. |
7611 NORTHLAND DRIVE | MINNEAPOLIS | MN | 55428 |
| K052459 | MEDTRONIC VASCULAR |
7000 CENTRAL AVENUE NE | MINNEAPOLIS | MN | 55432-3576 |
| K072556 | MERIT MEDICAL SYSTEMS, INC. |
1600 WEST MERIT PKWY. | SOUTH JORDAN | UT | 84095 |
| K993057 | MERIT MEDICAL SYSTEMS, INC. |
1600 WEST MERIT PKWY. | SOUTH JORDAN | UT | 84095 |
| K100319 | MERIT MEDICAL SYSTEMS, INC. |
1600 WEST MERIT PKWY. | SOUTH JORDAN | UT | 84095 |
| K143429 | MERIT MEDICAL SYSTEMS, INC. |
PARKMORE BUSINESS PARK WEST | GALWAY | ||
| K140475 | MERIT MEDICAL SYSTEMS, INC. |
1600 WEST MERIT PKWY. | SOUTH JORDAN | UT | 84095 |
| K042060 | MILLIMED A/S |
1327 BLUEGRASS WAY | GAMBRILLS | MD | 21054 |
| K961181 | NALTIAC MEDICAL, INC. |
17194 PRESTON RD. | DALLAS | TX | 75248 |
| K091634 | NAVILYST MEDICAL, INC. |
26 FOREST STREET | MARLBOROUGH | MA | 01752 |
| K955554 | NORTH AMERICAN INSTRUMENT CORP. |
PRUYNS ISLAND RD. | GLENS FALLS | NY | 12801 |
| K033328 | NOVOSCI CORP. |
2828 NORTH CRESCENT RIDGE DR. | THE WOODLANDS | TX | 77381-3902 |
| K992906 | OLSON MEDICAL SALES, INC. |
2101 COTTONTAIL LN. | SOMERSET | NJ | 08873 |
| K080472 | SEDAT |
8895 TOWNE CENTRE DRIVE | SAN DIEGO | CA | |
| K040498 | SEDAT S.A. |
4 HARVARD PLACE, # 1 | CHARLESTOWN | MA | 02129 |
| K170024 | SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD. |
NO. 925 JINYUAN YI RD | SHANGHAI | 201803 | |
| K113148 | SYNEXMED(SHENZHEN)COMPANY LIMITED |
B-11/F,Z Z Y BUILD.,TAOHUA RD. | SHENZHEN | 518038 | |
| K003604 | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K022918 | Terumo Cardiovascular Systems Corporation |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K041697 | Terumo Cardiovascular Systems Corporation |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K093992 | Terumo Cardiovascular Systems Corporation |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K073474 | TERUMO CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K072745 | THOMAS MEDICAL PRODUCTS, INC. |
65 GREAT VALLEY PKWY. | MALVERN | PA | 19355 |
| K122301 | VASCULAR SOLUTIONS ZERUSA LTD. |
6464 SYCAMORE COURT | MINNEAPOLIS | MN | 55369 |
| K092563 | VASCULAR SOLUTIONS, INC. |
6464 SYCAMORE COURT | MINNEAPOLIS | MN | 55369 |
| K073620 | ZERUSA LIMITED |
219-220 BUSINESS INNOVATION | GALWAY | ||
| K052381 | ZERUSA LIMITED |
219-220 BUSINESS INNOVATION | GALWAY | ||
| K092711 | ZERUSA LIMITED |
219-220 BUSINESS INNOVATION CR | GALWAY | ||
| K101113 | ZERUSA LIMITED |
219-220 BUSINESS INNOVATION | GALWAY |
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