The following data is part of a premarket notification filed by Izi Medical Products Llc with the FDA for Mdt Navigable Brain Biopsy Cannula.
| Device ID | K143241 |
| 510k Number | K143241 |
| Device Name: | MDT Navigable Brain Biopsy Cannula |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | IZI MEDICAL PRODUCTS LLC 5 Easter Ct Ste J Owings Mills, MD 21117 |
| Contact | Qiang Cao |
| Correspondent | Qiang Cao IZI MEDICAL PRODUCTS LLC 5 Easter Ct Ste J Owings Mills, MD 21117 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-12 |
| Decision Date | 2015-04-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815212024382 | K143241 | 000 |
| 00815212024375 | K143241 | 000 |
| 00815212026867 | K143241 | 000 |