FDA 510(k) Applications for Medical Device:
Electrode, Pacemaker, Temporary
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K962467 | ABBOTT LABORATORIES |
D-389, AP-30 | ABBOTT PARK | IL | 60064-3537 |
| K030556 | AESCULAP, INC. |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K960479 | ARROW INTL., INC. |
3000 BERNVILLE RD. | READING | PA | 19605 |
| K955829 | B. BRAUN MEDICAL, INC. |
824 TWELFTH AVE. | BETHLEHEM | PA | 18018 |
| K160260 | BIO TRACE MEDICAL, INC. |
831 BRANSTEN RD, SUITE L | SAN CARLOS | CA | 94070 |
| K242863 | Bioptimal International Pte. Ltd. |
36 Jalan Tukang #02-02 | Singapore | 619266 | |
| K971165 | BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. | NATICK | MA | 01760-1537 |
| K251186 | C. R. Bard, Inc. |
8195 Industrial Blvd. | Covington | GA | 30014 |
| K241334 | C. R. Bard, Inc. |
8195 Industrial Blvd. | Covington | GA | 30014 |
| K955712 | C.R. BARD, INC. |
1200 TECHNOLOGY PARK DR. | BILLERICA | MA | 01821 |
| K971775 | CARDIAC CONTROL SYSTEMS, INC. |
3 COMMERCE BLVD. | PALM COAST | FL | 32164 |
| K955722 | DAVIS & GECK, INC. |
ONE CASPER ST. | DANBURY | CT | 06810 |
| K152633 | EDWARDS LIFESCIENCES, LLC |
ONE EDWARDS WAY | IRVINE | CA | 92614 |
| K980503 | ETHICON, INC. |
ROUTE 22 WEST | SOMERVILLE | NJ | 08876-0151 |
| K173923 | Ethicon, Inc. |
Route 22 West, P.O. Box 151 | Somerville | NJ | 08876-0151 |
| K033858 | EUROPEAN CUSTOM MANUFACTURING BV |
OOST-OM 54 | GEMERT | ||
| K963073 | HARMAC MEDICAL PRODUCTS, INC. |
2201 BAILEY AVE. | BUFFALO | NY | 14211-1797 |
| K962833 | HARMAC MEDICAL PRODUCTS, INC. |
2201 BAILEY AVE. | BUFFALO | NY | 14211-1797 |
| K190716 | Medtronic |
1851 East Deere Ave. | Santa Ana | CA | 92705 |
| K171253 | Medtronic |
1851 East Deere Ave | Santa Ana | CA | 92705 |
| K161249 | Medtronic |
1801 East Deere Ave | Santa Ana | CA | 92705 |
| K242705 | Medtronic Inc |
710 Medtronic Parkway | Minneapolis | MN | 55432 |
| K040812 | MEDTRONIC VASCULAR |
1015 GRAMSIE RD | SHOREVIEW | MN | 55126-3082 |
| K973360 | MEDTRONIC VASCULAR |
7000 CENTRAL AVENUE, N.E. | MINNEAPOLIS | MN | 55432-3576 |
| K042190 | MEDTRONIC VASCULAR |
7000 CENTRAL AVE. N.E. | MINNEAPOLIS | MN | 55432-3576 |
| K012454 | MEDTRONIC VASCULAR |
7000 CENTRAL AVENUE NE | MINNEAPOLIS | MN | 55432-3576 |
| K012458 | MEDTRONIC VASCULAR |
7000 CENTRAL AVENUE NE | MINNEAPOLIS | MN | 55432-3576 |
| K012459 | MEDTRONIC VASCULAR |
7000 CENTRAL AVENUE NE | MINNEAPOLIS | MN | 55432-3576 |
| K012460 | MEDTRONIC VASCULAR |
7000 CENTRAL AVENUE NE | MINNEAPOLIS | MN | 55432-3576 |
| K963898 | MEDTRONIC VASCULAR |
7000 CENTRAL AVE. NE | MINNEAPOLIS | MN | 55432-3576 |
| K012452 | MEDTRONIC VASCULAR |
7000 CENTRAL AVENUE NE | MINNEAPOLIS | MN | 55432-3576 |
| K961520 | MEDTRONIC VASCULAR |
7000 CENTRAL AVENUE, N.E. | MINNEAPOLIS | MN | 55432-3576 |
| K140972 | MEDTRONIC, INC. |
1851 EAST DEERE AVE. | SANTA ANA | CA | 92705 |
| K072770 | Oscor Inc. |
3816 DE SOTO BLVD. | PALM HARBOR | FL | 34683 |
| K232261 | Osypka AG |
Earl-H.-Wood Str. 1 | Rheinfelden | 79618 | |
| K032613 | PETER M. ROTHENBERG, M.D. |
657 CAMINO DE LOS MARES | SAN CLEMENTE | CA | 92673 |
| K023174 | RIVER MEDICAL, INC. |
836 NE 24TH AVE. | PORTLAND | OR | 97232 |
| K241199 | Shenzhen Launch Electrical Co. Ltd |
Bldg F, Zhonggangxing Industrial Estate Zhangge Community | Shenzhen | 518110 | |
| K152784 | ST. JUDE MEDICAL |
14901 DEVEAU PLACE | MINNETONKA | MN | 55345 |
| K161873 | St. Jude Medical |
14901 DeVeau Place | Minnetonka | MN | 55345 |
| K011660 | WECK CLOSURE SYSTEMS |
ONE WECK DR. | RESEARCH TRIANGLE PARK | NC | 27709 |
| K002603 | ZCV ,INC. |
298 FERNWOOD AVE. | EDISON | NJ | 08837 |
| K002481 | ZCV ,INC. |
298 FERNWOOD AVE. | EDISON | NJ | 08837 |
| K010099 | ZCV ,INC. |
298 FERNWOOD AVE. | EDISON | NJ | 08837 |
| K002687 | ZYNERGY CARDIOVASCULAR, INC. |
298 FERNWOOD AVE. | EDISON | NJ | 08837-3839 |
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