FDA 510(k) Applications for Medical Device:
Catheter,Intracardiac Mapping,High-Density Array
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K153093 | ABBOTT ELECTROPHYSIOLOGY |
1530 OBRIEN DRIVE | MENLO PARK | CA | 94025 |
| K163709 | ABBOTT ELECTROPHYSIOLOGY |
1530 OBRIEN DRIVE | MENLO PARK | CA | 94025 |
| K223666 | Ablacon, Inc. |
4800 Wadsworth Blvd Suite 310 | Wheat Ridge | CO | 80033 |
| K170819 | Acutus Medical, Inc. |
2210 Faraday Ave., Ste 100 | Carlsbad | CA | 92008 |
| K201341 | Acutus Medical, Inc. |
2210 Faraday Ave., Suite 100 | Carlsbad | CA | 92008 |
| K210766 | Acutus Medical, Inc. |
2210 Faraday Ave, Suite 100 | Carlsbad | CA | 92008 |
| K231312 | Biosense Webster Inc. |
31 Technology Drive, Suite 200 | Irvine | CA | 92618 |
| K201750 | Biosense Webster, Inc |
33 Technology Dr | Irvine | CA | 92618 |
| K193237 | Biosense Webster, Inc. |
33 Technology Dr | Irvine | CA | 92618 |
| K050217 | BIOSENSE WEBSTER, INC. |
3333 DIAMOND CANYON RD. | DIAMOND BAR | CA | 91765 |
| K211438 | Biosense Webster, Inc. |
31 Technology Drive Suite 200 | Irvine | CA | 92618 |
| K230253 | Biosense Webster, Inc. |
31 Technology Drive, Suite 200 | Irvine | CA | 92618 |
| K123837 | BIOSENSE WEBSTER, INC. |
3333 DIAMOND CANYON RD. | DIAMOND BAR | CA | 91765 |
| K120425 | BIOSENSE WEBSTER, INC. |
3333 DIAMOND CANYON RD. | DIAMOND BAR | CA | 91765 |
| K003782 | BOSTON SCIENTIFIC CORP. |
2710 ORCHARD PKWY. | SAN JOSE | CA | 95134 |
| K000277 | BOSTON SCIENTIFIC CORP. |
2710 ORCHARD PKWY. | SAN JOSE | CA | 95134 |
| K021232 | BOSTON SCIENTIFIC CORP. |
2710 ORCHARD PKWY. | SAN JOSE | CA | 95134 |
| K992777 | BOSTON SCIENTIFIC CORP. |
2710 ORCHARD PKWY. | SAN JOSE | CA | 95134 |
| K983171 | BOSTON SCIENTIFIC CORP. |
2710 ORCHARD PKWY. | SAN JOSE | CA | 95134 |
| K140733 | Boston Scientific Corporation |
150 BAYTECH DRIVE | SAN JOSE | CA | 95124 |
| K982540 | CARDIAC PATHWAYS CORP. |
995 BENECIA AVE. | SUNNYVALE | CA | 94086 |
| K990795 | CARDIAC PATHWAYS CORP. |
995 BENECIA AVE. | SUNNYVALE | CA | 94086 |
| K983456 | ENDOCARDIAL SOLUTIONS, INC. |
1350 ENERGY LN., SUITE 110 | ST. PAUL | MN | 55108 |
| K012926 | ENDOCARDIAL SOLUTIONS, INC. |
1350 ENERGY LN., SUITE 110 | ST. PAUL | MN | 55108 |
| K200212 | Innovative Health, LLC. |
1435 North Hayden Road, Suite 100 | Scottsdale | AZ | 85257 |
| K121006 | ST. JUDE MEDICAL |
14901 DEVEAU PL. | MINNETONKA | MN | 55345-2126 |
| K172393 | St. Jude Medical, Inc. |
5050 Nathan Lane N | Plymouth | MN | 55442 |
| K201806 | Sterilmed Inc. (Johnson and Johnson) |
5010 Cheshire Parkway N, Suite 2 | Plymouth | MN | 55446 |
| K130827 | TOPERA, INC. |
3668 S. GEYER ROAD | ST. LOUIS | MO | 63127 |
| K142182 | TOPERA, INC. |
3668 S. GEYER ROAD | ST. LOUIS | MO | 63127 |
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