Navik 3D
FDA 510(k) clearance K152160 · decided 2016-02-23
Clearance details
- K-number
- K152160
- Device name
- Navik 3D
- Applicant
- Apn Health, LLC
- Decision
- Substantially Equivalent
- Date received
- 2015-08-03
- Decision date
- 2016-02-23
- Days to decision
- 204 days
- Clearance type
- Traditional
- Product code
- DQK
- Device class
- 2
- Regulation number
- 870.1425
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Pleasanton, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Navik 3D v2, REF NAVIK3D, 3D Mapping System recall (Z-0556-2024) | APN Health LLC | 2023-12-14 |