Mri Interventions, Inc.
Irvine, CA, US
Mri Interventions, Inc. appears in FDA device records in Irvine, CA. FDA records list 14 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 14
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 14 510(k) clearances for Mri Interventions, Inc. between 2011 and 2020. The busiest year on record is 2013, with 2. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 1 |
| 2013 | 2 |
| 2014 | 1 |
| 2015 | 2 |
| 2016 | 2 |
| 2017 | 1 |
| 2018 | 2 |
| 2019 | 2 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K200079 | ClearPoint System and Accessories | HAW | Substantially Equivalent | |
| K191701 | Arcus Head Fixation Frame | HBL | Substantially Equivalent | |
| K191400 | Voyager Trajectory Array Guide (V-TAG) | HAW | Substantially Equivalent | |
| K181731 | MR Compatible Aspiration Kit | GWG | Substantially Equivalent | |
| K181195 | ClearPoint System | ORR | Substantially Equivalent | |
| K171257 | ClearPoint System | ORR | Substantially Equivalent | |
| K160129 | MRII Cranial Drill and Accessories | HBG | Substantially Equivalent | |
| K160434 | ClearPoint System | HAW | Substantially Equivalent | |
| K142505 | ClearPoint System | HAW | Substantially Equivalent | |
| K151536 | SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm | HBG | Substantially Equivalent | |
| K132436 | VARIOGUIDE DRILL KIT | HBE | Substantially Equivalent | |
| K123605 | SMARTFLOW CATHETER | HCA | Substantially Equivalent | |
| K122456 | MRII CRAINIAL DRILL | HBG | Substantially Equivalent | |
| K111802 | SV BRAIN ARRAY, SIEMENS 3T | MOS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- HCACatheter, Ventricular
- MOSCoil, Magnetic Resonance, Specialty
- HBGDrills, Burrs, Trephines & Accessories (Manual)
- HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)
- GWGEndoscope, Neurological
- HBLHolder, Head, Neurosurgical (Skull Clamp)
- HAWNeurological Stereotaxic Instrument
- ORRNeurological Stereotaxic Instrument, Real-Time Intraoperative Mri
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain