Submission Details
| 510(k) Number | K191400 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 24, 2019 |
| Decision Date | June 21, 2019 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Special
Voyager Trajectory Array Guide (V-TAG)
Jun 2019
Decision
28d
Days
Class 2
Risk
About This 510(k) Submission
K191400 is an FDA 510(k) clearance for the Voyager Trajectory Array Guide (V-TAG), a Neurological Stereotaxic Instrument (Class II — Special Controls, product code HAW), submitted by Mri Interventions, Inc. (Irvine, US). The FDA issued a Cleared decision on June 21, 2019, 28 days after receiving the submission on May 24, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.
Device Classification
| Product Code | HAW — Neurological Stereotaxic Instrument |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 882.4560 |
Manufacturer
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