510(k) K180854
K180854 is an FDA 510(k) premarket notification submitted by Voyager Therapeutics, Inc. for the device "Voyager Trajectory Array Guide (V-TAG)". The FDA issued a decision of Substantially Equivalent on Jul 23, 2018. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 23, 2018
- Date Received
- Apr 2, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Neurological Stereotaxic Instrument
- Device Class
- Class II
- Regulation Number
- 882.4560
- Review Panel
- NE
- Submission Type
- 510(k)