FDA 510(k) Applications for Medical Device:
Catheter, Irrigation
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K973703 | ALLEGIANCE HEALTHCARE CORP. |
1430 WAUKEGAN RD. | MCGAW PARK | IL | 60085 |
| K965146 | AXIOM MEDICAL, INC. |
555 WEST VICTORIA ST. | RANCHO DOMINGUEZ | CA | 90220 |
| K961147 | B. BRAUN MEDICAL, INC. |
824 TWELFTH AVE. | BETHLEHEM | PA | 18018 |
| K960955 | BAXTER HEALTHCARE CORP. |
1500 WAUKEGAN RD. | MCGAW PARK | IL | 60085 |
| K000704 | DMC MEDICAL LTD. |
511 CATALINA RD. | FULLERTON | CA | 92835 |
| K955474 | INTRA SPECIAL CATHETERS GMBH |
1247 FLORIDA AVE. | PALM HABOR | FL | 34683 |
| K974233 | LYSONIX, INC. |
1170 MARK AVE. | CARPINTERIA | CA | 93013 |
| K082725 | MAQUET CARDIOVASCULAR, LLC |
170 BAYTECH DRIVE | SAN JOSE | CA | 95134 |
| K013417 | MISONIX, INC. |
1938 NEW HIGHWAY | FARMINGDALE | NY | 11735 |
| K131659 | MOERAE MATRIX, INC. |
25 HARTFORD AVENUE | SAN CARLOS | CA | 94070 |
| K955505 | NAVARRE BIOMEDICAL LTD. |
2545 FERNBROOK LN. NORTH | PLYMOUTH | MN | 55447 |
| K955339 | NORTHGATE TECHNOLOGIES, INC. |
600 CHURCH RD. | ELGIN | IL | 60123 |
| K961295 | SIL-MED CORP. |
700 WARNER BLVD. | TAUNTON | MA | 02780 |
| K052286 | THE CATHETER EXCHANGE, INC. |
16633 VENTURA BLVD. | ENCINO | CA | 91436 |
| K972635 | ULTRACELL MEDICAL TECHNOLOGIES, INC. |
183 PROVIDENCE, | NORTH STONINGTON | CT | 06359 |
| K043515 | VESCARE, INC. |
28 COOK ST. | BILLERICA | MA | 01821 |
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