FDA 510(k) Applications for Medical Device:
Catheter, Electrode Recording, Or Probe, Electrode Recording
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K192037 | Abbott Medical |
5050 Nathan Lane North | Plymouth | MN | 55442 |
| K160390 | ACCESS POINT TECHNOLOGIES EP, INC. |
12560 LOCATED AT FLETCHER LANE | Rogers | MN | 55374 |
| K042105 | BARD ELECTROPHYSIOLOGY |
55 TECHNOLOGY DR. | LOWELL | MA | 01851 |
| K183649 | Baylis Medical Company Inc. |
2580 Matheson Blvd. E | Mississauga | L4W 4J1 | |
| K183632 | Baylis Medical Company Inc. |
2580 Matheson Blvd. E | Mississauga | L4W 4J1 | |
| K002333 | BIOSENSE WEBSTER, INC. |
3333 DIAMOND CANYON RD. | DIAMOND BAR | CA | 91765 |
| K060047 | BIOSENSE WEBSTER, INC. |
3333 DIAMOND CANYON RD. | DIAMOND BAR | CA | 91765 |
| K050877 | BIOSENSE WEBSTER, INC. |
3333 DIAMOND CANYON RD. | DIAMOND BAR | CA | 91765 |
| K090898 | BIOSENSE WEBSTER, INC. |
3333 DIAMOND CANYON RD. | DIAMOND BAR | CA | 91765 |
| K080425 | BIOSENSE WEBSTER, INC. |
3333 DIAMOND CANYON RD. | DIAMOND BAR | CA | 91765 |
| K061463 | BIOSENSE WEBSTER, INC. |
3333 DIAMOND CANYON RD. | DIAMOND BAR | CA | 91765 |
| K113213 | BIOSENSE WEBSTER, INC. |
3333 DIAMOND CANYON RD | DIAMOND BAR | CA | 91765 |
| K093376 | BIOSENSE WEBSTER, INC. |
3333 DIAMOND CANYON RD. | DIAMOND BAR | CA | 91765 |
| K130602 | BIOSENSE WEBSTER, INC. |
3333 DIAMOND CANYON RD | DIAMOND BAR | CA | 91765 |
| K193632 | Biosense Webster, Inc. |
33 Technology Drive | Irvine | CA | 92618 |
| K211219 | Biosense Webster, Inc. |
31 Technology Drive Suite 200 | Irvine | CA | 92618 |
| K052083 | BIOSENSE WEBSTER, INC. |
3333 DIAMOND CANYON RD. | DIAMOND BAR | CA | 91765 |
| K061468 | BIOSENSE WEBSTER, INC. |
3333 DIAMOND CANYON RD. | DIAMOND BAR | CA | 91765 |
| K090120 | BIOSENSE WEBSTER, INC. |
3333 DIAMOND CANYON RD. | DIAMOND BAR | CA | 91765 |
| K042998 | BIOSENSE WEBSTER, INC. |
3333 DIAMOND CANYON RD. | DIAMOND BAR | CA | 91765 |
| K031161 | BIOSENSE WEBSTER, INC. |
3333 DIAMOND CANYON RD. | DIAMOND BAR | CA | 91765 |
| K081258 | BIOSENSE WEBSTER, INC. |
3333 DIAMOND CANYON RD. | DIAMOND BAR | CA | 91765 |
| K101345 | BIOSENSE WEBSTER, INC. |
3333 DIAMOND CANYON RD. | DIAMOND BAR | CA | 91765 |
| K101991 | BIOSENSE WEBSTER, INC. |
3333 DIAMOND CANYON RD. | DIAMOND BAR | CA | 91765 |
| K960542 | BIOSENSE, LTD. |
EINSTEIN BUILDING, ETGAR ST. | TIRAT HACARMEL, HAIFA | 39101 | |
| K212593 | Biotronick, Inc. |
6024 Jean Road | Lake Oswego | OR | 97035 |
| K201445 | Biotronik, Inc |
6024 Jean Road | Lake Oswego | OR | 97035 |
| K230503 | Boston Scientific |
4100 Hamline Ave N | St.Paul | MN | 55112-5798 |
| K081576 | BOSTON SCIENTIFIC CORP. |
150 BAYTECH DRIVE | SAN JOSE | CA | 95134 |
| K953750 | BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. | NATICK | MA | 01760-1537 |
| K954651 | BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. | NATICK | MA | 01760-1537 |
| K211375 | Boston Scientific Corporation |
4100 Hamline Ave North | St. Paul | MN | 55112-5798 |
| K232651 | Boston Scientific Corporation |
4100 Hamline Ave North | St. Paul | MN | 55112-5798 |
| K240366 | Boston Scientific Corporation |
4100 Hamline Ave North | St Paul | MN | 55112 |
| K220796 | Boston Scientific Corporation |
4100 Hamline Ave North | St. Paul | MN | 55112 |
| K192360 | Boston Scientific Corporation |
4100 Hamline Ave North | St.Paul | MN | 55112 |
| K211494 | Boston Scientific Corporation |
4100 Hamline Ave North | St. Paul | MN | 55112-5798 |
| K233207 | Boston Scientific Corporation |
4100 Hamline Avenue North | St. Paul | MN | 55112-5798 |
| K250310 | Boston Scientific Corporation |
4100 Hamline Ave North | Saint Paul | MN | 55112 |
| K030627 | C.R. BARD, INC. |
55 TECHNOLOGY DR. | LOWELL | MA | 01851 |
| K992373 | C.R. BARD, INC. |
55 TECHNOLOGY DR., SUITE 1 | LOWELL | MA | 01851 |
| K091370 | C.R. BARD, INC. |
55 TECHNOLOGY DRIVE | LOWELL | MA | 01851 |
| K971265 | C.R. BARD, INC. |
129 CONCORD RD. | BILLERICA | MA | 01821 |
| K955847 | CARDIAC ASSIST DEVICES, INC. |
11000 CEDAR AVE., SUITE 451 | CLEVELAND | OH | 44106-3052 |
| K012520 | CARDIAC ASSIST DEVICES, INC. |
11000 CEDAR AVE., SUITE 451 | CLEVELAND | OH | 44106-3052 |
| K965066 | CARDIAC PATHWAYS CORP. |
995 BENECIA AVE. | SUNNYVALE | CA | 94086 |
| K992912 | CARDIAC PATHWAYS CORP. |
995 BENECIA AVE. | SUNNYVALE | CA | 94086 |
| K983653 | CARDIAC PATHWAYS CORP. |
995 BENECIA AVE. | SUNNYVALE | CA | 94086 |
| K971975 | CARDIMA, INC. |
47266 BENICIA ST. | FREMONT | CA | 94539-1372 |
| K982835 | CARDIMA, INC. |
47266 BENICIA ST. | FREMONT | CA | 94538-1372 |
| K955802 | CARDIMA, INC. |
47266 BENICIA ST. | FREMONT | CA | 94539-1372 |
| K970853 | CARDIMA, INC. |
47266 BENICIA ST. | FREMONT | CA | 94538-1372 |
| K972803 | CARDIMA, INC. |
47266 BENICIA ST. | FREMONT | CA | 94538-1372 |
| K011361 | CATHEFFECTS, LLC. |
1100 MELODY LANE; SUITE 108 | ROSEVILLE | CA | 95678 |
| K211327 | CathRxLtd |
Unit 8, 2-8 South St | Rydalmere | 2116 | |
| K000753 | CORDIS CORP. |
14201 N.W. 60TH AVE. | MIAMI LAKES | FL | 33014 |
| K991531 | CORDIS WEBSTER, INC. |
4750 LITTLEJOHN ST. | BALDWIN PARK | CA | 91706 |
| K992965 | CORDIS WEBSTER, INC. |
4750 LITTLEJOHN ST. | BALDWIN PARK | CA | 91706 |
| K980961 | CORDIS WEBSTER, INC. |
4750 LITTLEJOHN ST. | BALDWIN PARK | CA | 91706 |
| K982415 | CORDIS WEBSTER, INC. |
4750 LITTLEJOHN ST. | BALDWIN PARK | CA | 91706 |
| K953663 | CORDIS WEBSTER, INC. |
4750 LITTLEJOHN ST. | BALDWIN PARK | CA | 91706 |
| K955817 | CORDIS WEBSTER, INC. |
4750 LITTLEJOHN ST. | BALDWIN PARK | CA | 91706 |
| K991001 | EP MEDSYSTEMS |
COOPER RUN EXECUTIVE PARK | WEST BERLIN | NJ | 08091 |
| K984150 | EP MEDSYSTEMS |
COOPER RUN EXECUTIVE PARK | WEST BERLIN | NJ | 08091 |
| K033963 | EP MEDSYSTEMS, INC. |
COOPER RUN EXECUTIVE PARK | WEST BERLIN | NJ | 08091-9293 |
| K003452 | EP TECHNOLOGIES, INC. |
2710 ORCHARD PKWY. | SAN JOSE | CA | 95134 |
| K043257 | EP TECHNOLOGIES, INC. |
2710 ORCHARD PKWY. | SAN JOSE | CA | 95134 |
| K962307 | FIDUS MEDICAL TECHNOLOGY CORP. |
47929 FREMONT BLVD. | FREMONT | CA | 94538 |
| K963074 | HARMAC MEDICAL PRODUCTS, INC. |
2201 BAILEY AVE. | BUFFALO | NY | 14211-1797 |
| K191880 | Innovative Health, LLC. |
1435 North Hayden Road, Suite 100 | Scottsdale | AZ | 85257 |
| K203261 | Innovative Health, LLC. |
1435 North Hayden Road | Scottsdale | AZ | 85257 |
| K171277 | Innovative Health, LLC. |
1435 North Hayden Road, Suite 100 | Scottsdale | AZ | 85257 |
| K182386 | Innovative Health, LLC. |
1435 North Hayden Road, Suite 100 | Scottsdale | AZ | 85257 |
| K161769 | INNOVATIVE HEALTH, LLC. |
1435 NORTH HAYDEN ROAD | SCOTTSDALE | AZ | 85257 |
| K190980 | Innovative Health, LLC. |
1435 North Hayden Road, Suite 100 | Scottsdale | AZ | 85257 |
| K010471 | IRVINE BIOMEDICAL, INC. |
2146-A MICHELSON DR. | IRVINE | CA | 92612 |
| K961924 | IRVINE BIOMEDICAL, INC. |
214A MICHELSON DR. | IRVINE | CA | 92715 |
| K053582 | IRVINE BIOMEDICAL, INC. |
2375 MORSE AVE. | IRVINE | CA | 92614 |
| K042775 | IRVINE BIOMEDICAL, INC. |
2375 MORSE AVE. | IRVINE | CA | 92614 |
| K082061 | IRVINE BIOMEDICAL, INC. |
2375 MORSE AVE. | IRVINE | CA | 92614 |
| K060757 | IRVINE BIOMEDICAL, INC. |
2375 MORSE AVE. | IRVINE | CA | 92614 |
| K991025 | IRVINE BIOMEDICAL, INC. |
2146-A MICHELSON DR. | IRVINE | CA | 92612 |
| K991878 | IRVINE BIOMEDICAL, INC. |
2146-A MICHELSON DR. | IRVINE | CA | 92612 |
| K982232 | IRVINE BIOMEDICAL, INC. |
2146-A MICHELSON DR. | IRVINE | CA | 92612 |
| K990958 | IRVINE BIOMEDICAL, INC. |
2146-A MICHELSON DR. | IRVINE | CA | 92612 |
| K973639 | J-LLOYD MEDICAL, INC. |
415 COMMERCE LANE, SUITE 7 | WEST BERLIN | NJ | 08091 |
| K971504 | J-LLOYD MEDICAL, INC. |
415 COMMERCE LANE, SUITE 7 | WEST BERLIN | NJ | 08091 |
| K151139 | MedFact Engineering GmbH |
Hammerstr.3 | Loerrach, Baden-Wurttemberg | D-79540 | |
| K183547 | Medtronic |
8200 Coral Sea St NE | Mounds View | MN | 55112 |
| K190132 | Medtronic |
8200 Coral Sea St NE | Mounds View | MN | 55112 |
| K102588 | MEDTRONIC ABLATION FRONTIERS, LLC |
2210 FARADAY AVENUE | CARLSBAD | CA | 92008 |
| K964272 | MEDTRONIC CARDIORHYTHM |
1312 CROSSMAN AVE. | SUNNYVALE | CA | 94089-1113 |
| K953185 | MEDTRONIC CARDIORHYTHM |
130 RIO ROBLES | SAN JOSE | CA | 95134-1806 |
| K981642 | MEDTRONIC CARDIORHYTHM |
1312 CROSSMAN AVE. | SUNNYVALE | CA | 94089-1113 |
| K162892 | MEDTRONIC INC. |
8200 CORAL SEA STREET NE | MOUNDS VIEW | MN | 55112 |
| K033050 | MEDTRONIC VASCULAR |
7000 CENTRAL AVE. NE | MINNEAPOLIS | MN | 55432-3576 |
| K153139 | MEDTRONIC, INC. |
8200 CORAL SEA STREET NE | MOUNDS VIEW | MN | 55112 |
| K233397 | Medtronic, Inc. |
8200 Coreal Sea Street NE | Mounds View | MN | 55112 |
| K030852 | MOGUL ENTERPRISES |
6387 SAN IGNACIO AVE. | SAN JOSE | CA | 95119 |
| K011734 | MOGUL ENTERPRISES |
6387 SAN IGNACIO AVE. | SAN JOSE | CA | 95119 |
| K993698 | MOGUL ENTERPRISES |
6387 SAN IGNACIO AVE. | SAN JOSE | CA | 95119 |
| K061678 | PRORHYTHM |
105 COMAC ST. | RONKONKOMA | NY | 11779 |
| K143481 | RHYTHMIA MEDICAL, INC |
111 SOUTH BEDFORD ST SUITE 205 | BURLINGTON | MA | 01803 |
| K122461 | RHYTHMIA MEDICAL, INC |
111 SOUTH BEDFORD ST SUITE 205 | BURLINGTON | MA | 01803 |
| K210313 | Shanghai MicroPort EP MedTech Co., Ltd. |
Building 23&28, Lane 588, Tianxiong Rd. | Shanghai | 201318 | |
| K011766 | ST. JUDE MEDICAL |
14901 DEVEAU PL. | MINNETONKA | MN | 55345-2126 |
| K160335 | St. Jude Medical |
5050 Nathan Lane | Plymouth | MN | 55442 |
| K101623 | ST. JUDE MEDICAL |
2375 MORSE AVENUE | IRVINE | CA | 92614-6233 |
| K022380 | ST. JUDE MEDICAL |
14900 MINNETONKA INDUSTRIAL BL | MINNETONKA | MN | 55345 |
| K102721 | ST. JUDE MEDICAL |
14901 DEVEAU PL. | MINNETONKA | MN | 55345-2126 |
| K080179 | ST. JUDE MEDICAL |
14901 DEVEAU PL. | MINNETONKA | MN | 55345-2126 |
| K072012 | ST. JUDE MEDICAL |
14901 DEVEAU PL. | MINNETONKA | MN | 55345-2126 |
| K062251 | ST. JUDE MEDICAL |
14901 DEVEAU PL. | MINNETONKA | MN | 55345-2126 |
| K002976 | ST. JUDE MEDICAL |
14901 DEVEAU PLACE | MINNETONKA | MN | 55345 |
| K120544 | ST. JUDE MEDICAL |
14901 DEVEAU PL. | MINNETONKA | MN | 55345-2126 |
| K101955 | ST. JUDE MEDICAL |
14901 DEVEAU PL. | MINNETONKA | MN | 55345-2126 |
| K081803 | ST. JUDE MEDICAL |
14901 DEVEAU PL. | MINNETONKA | MN | 55345-2126 |
| K150631 | St. Jude Medical |
14901 De Veau Place | Minnetonka | MN | 55345-2126 |
| K151622 | St. Jude Medical |
14901 DeVeau Place | Minnetonka | MN | 55345 |
| K250590 | Stereotaxis, Inc. |
710 N. Tucker Blvd | St. Louis | MO | 63101 |
| K013484 | STEREOTAXIS, INC. |
4041 FOREST PARK BLVD. | ST. LOUIS | MO | 63108 |
| K233900 | Synaptic Medical Corporation |
1959 Kellogg Avenue | Carlsbad | CA | 92008 |
| K203793 | Synaptic Medical Corporation |
1817 Aston Ave Suite 101 | Carlsbad | CA | 92008 |
| K133028 | SYNAPTIC MEDICAL LIMITED |
P.O. BOX 120-119 | SHANGHAI | 200120 | |
| K021421 | TZ MEDICAL, INC. |
7272 S.W. DURHAM RD., #800 | PORTLAND | OR | 97224 |
| K991060 | ZCV ,INC. |
298 FERNWOOD AVE. | EDISON | NJ | 08837 |
| K011847 | ZYNERGY CARDIO VASULAR (ZCV), INC. |
298 FERNWOOD AVE. | EDISON | NJ | 08837 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
