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 |
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 |
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 |
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 |
K013484 |
STEREOTAXIS, INC. |
4041 FOREST PARK BLVD.
| ST. LOUIS |
MO |
63108 |
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 |
|
|