SPIN DRIVE ALWAYS-ON TIP TRACKED STEERABLE CATHETER ALWAYS-ON TIP TRACKED SHEATH ALWAYS-ON TIP TRACKED ASPIRATION NEEDLE

System, X-ray, Tomography, Computed

VERAN MEDICAL TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Veran Medical Technologies, Inc. with the FDA for Spin Drive Always-on Tip Tracked Steerable Catheter Always-on Tip Tracked Sheath Always-on Tip Tracked Aspiration Needle.

Pre-market Notification Details

Device IDK122106
510k NumberK122106
Device Name:SPIN DRIVE ALWAYS-ON TIP TRACKED STEERABLE CATHETER ALWAYS-ON TIP TRACKED SHEATH ALWAYS-ON TIP TRACKED ASPIRATION NEEDLE
ClassificationSystem, X-ray, Tomography, Computed
Applicant VERAN MEDICAL TECHNOLOGIES, INC. 1908 Innerbelt Business Center Dr Saint Louis,  MO  63114
ContactScott Wrightstone
CorrespondentScott Wrightstone
VERAN MEDICAL TECHNOLOGIES, INC. 1908 Innerbelt Business Center Dr Saint Louis,  MO  63114
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-07-17
Decision Date2012-12-21
Summary:summary

NIH GUDID Devices

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