MDT Navigable Brain Biopsy Cannula

Neurological Stereotaxic Instrument

IZI MEDICAL PRODUCTS LLC

The following data is part of a premarket notification filed by Izi Medical Products Llc with the FDA for Mdt Navigable Brain Biopsy Cannula.

Pre-market Notification Details

Device IDK143241
510k NumberK143241
Device Name:MDT Navigable Brain Biopsy Cannula
ClassificationNeurological Stereotaxic Instrument
Applicant IZI MEDICAL PRODUCTS LLC 5 Easter Ct Ste J Owings Mills,  MD  21117
ContactQiang Cao
CorrespondentQiang Cao
IZI MEDICAL PRODUCTS LLC 5 Easter Ct Ste J Owings Mills,  MD  21117
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-11-12
Decision Date2015-04-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00815212024382 K143241 000
00815212024375 K143241 000
00815212026867 K143241 000
00815212024467 K143241 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.