Novasight Hybrid System

Catheter, Ultrasound, Intravascular

Conavi Medical Inc.

The following data is part of a premarket notification filed by Conavi Medical Inc. with the FDA for Novasight Hybrid System.

Pre-market Notification Details

Device IDK172258
510k NumberK172258
Device Name:Novasight Hybrid System
ClassificationCatheter, Ultrasound, Intravascular
Applicant Conavi Medical Inc. 293 Lesmill Road Toronto,  CA M3b2v1
ContactSam Mostafavi
CorrespondentSam Mostafavi
Conavi Medical Inc. 293 Lesmill Road Toronto,  CA M3b2v1
Product CodeOBJ  
Subsequent Product CodeIYO
Subsequent Product CodeNQQ
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-26
Decision Date2018-04-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
01628055603053 K172258 000
00628055603108 K172258 000
00628055603085 K172258 000
00628055603078 K172258 000
00628055603061 K172258 000
00628055603092 K172258 000
00628055603115 K172258 000

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