The following data is part of a premarket notification filed by Novate Medical Ltd. with the FDA for Sentry Ivc Filter.
| Device ID | K162875 |
| 510k Number | K162875 |
| Device Name: | Sentry IVC Filter |
| Classification | Filter, Intravascular, Cardiovascular |
| Applicant | NOVATE MEDICAL LTD. BLOCK 11, GALWAY TECHNOLOGY PARK, PARKMORE Galway, IE |
| Contact | Gordon Crowley |
| Correspondent | Gordon Crowley NOVATE MEDICAL LTD. BLOCK 11, GALWAY TECHNOLOGY PARK, PARKMORE Galway, IE |
| Product Code | DTK |
| CFR Regulation Number | 870.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-14 |
| Decision Date | 2017-02-17 |
| Summary: | summary |