Relieva SpinPlus Nav Balloon Sinuplasty System

Instrument, Ent Manual Surgical

Acclarent, Inc.

The following data is part of a premarket notification filed by Acclarent, Inc. with the FDA for Relieva Spinplus Nav Balloon Sinuplasty System.

Pre-market Notification Details

Device IDK171687
510k NumberK171687
Device Name:Relieva SpinPlus Nav Balloon Sinuplasty System
ClassificationInstrument, Ent Manual Surgical
Applicant Acclarent, Inc. 33 Technology Drive Irvine,  CA  92618
ContactJames Patrick Garvey Ii
CorrespondentJames Patrick Garvey Ii
Acclarent, Inc. 33 Technology Drive Irvine,  CA  92618
Product CodeLRC  
CFR Regulation Number874.4420 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-07
Decision Date2017-09-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20705031245430 K171687 000
20705031245423 K171687 000
20705031241012 K171687 000
20705031241005 K171687 000

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