The following data is part of a premarket notification filed by Mri Interventions, Inc. with the FDA for Varioguide Drill Kit.
| Device ID | K132436 |
| 510k Number | K132436 |
| Device Name: | VARIOGUIDE DRILL KIT |
| Classification | Drills, Burrs, Trephines & Accessories (simple, Powered) |
| Applicant | MRI INTERVENTIONS, INC. 5 MUSICK Irvine, CA 92618 |
| Contact | E. F Waddell |
| Correspondent | E. F Waddell MRI INTERVENTIONS, INC. 5 MUSICK Irvine, CA 92618 |
| Product Code | HBE |
| CFR Regulation Number | 882.4310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-05 |
| Decision Date | 2014-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056481006402 | K132436 | 000 |