PleuraFlow System

Wound Drain Catheter System

CLEARFLOW, INC.

The following data is part of a premarket notification filed by Clearflow, Inc. with the FDA for Pleuraflow System.

Pre-market Notification Details

Device IDK153681
510k NumberK153681
Device Name:PleuraFlow System
ClassificationWound Drain Catheter System
Applicant CLEARFLOW, INC. S. SUNKIST ST, SUITE E Anaheim,  CA  92806
ContactDov Gal
CorrespondentDov Gal
CLEARFLOW, INC. S. SUNKIST ST, SUITE E Anaheim,  CA  92806
Product CodeOTK  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-12-22
Decision Date2016-01-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10856449006045 K153681 000

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