FDA 510(k) Applications for Medical Device:
Valvulotome
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K250105 | Aveera Medical, Inc. |
929 Calle Negocio, Suite A | San Clemente | CA | 92673 |
| K965137 | BAXTER EDWARDS |
17221 RED HILL AVE. | IRVINE | CA | 92614-5627 |
| K001734 | EDWARDS LIFESCIENCES, LLC. |
ONE EDWARDS WAY | IRVINE | CA | 92614 |
| K022823 | GEISTER MEDIZINTECHNIK GMBH |
152B BRIDGE ST. | HOT SPRINGS | NC | 28743 |
| K080178 | KOVEN TECHNOLOGY, INC. |
11874 SOUTH EVELYN CIRCLE | HOUSTON | TX | 77071-3404 |
| K190267 | LeMaitre Vascular |
63 Second Avenue | Burlington | MA | 01803 |
| K140042 | LEMAITRE VASCULAR, INC. |
63 SECOND AVENUE | BURLINGTON | MA | 01803 |
| K142660 | LeMaitre Vascular, Inc. |
63 Second Avenue | Burlington | MA | 01803 |
| K132190 | LEMAITRE VASCULAR, INC. |
63 2ND AVENUE | BURLINGTON | MA | 01803 |
| K132047 | LEMAITRE VASCULAR, INC. |
63 SECOND AVENUE | BURLINGTON | MA | 01803 |
| K111884 | LEMAITRE VASCULAR, INC. |
63 2ND AVENUE | BURLINGTON | MA | 01803 |
| K221902 | LimFlow, Inc. |
3031 Tisch Way - 110 Plaza West | San Jose | CA | 95128 |
| K980723 | VASCUTECH, INC. |
164 MIDDLESEX TURNPIKE | BURLINGTON | MA | 01803 |
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