The ZIP Accessory Shuttle For 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 The Zip Accessory Shuttle For Pleuraflow System.

Pre-market Notification Details

Device IDK191733
510k NumberK191733
Device Name:The ZIP Accessory Shuttle For PleuraFlow System
ClassificationWound Drain Catheter System
Applicant ClearFlow, Inc. 1630 S. Sunkist St. Suite E Anaheim,  CA  92806
ContactDov Gal
CorrespondentDov Gal
ClearFlow, Inc. 1630 S. Sunkist St. Suite E Anaheim,  CA  92806
Product CodeOTK  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-28
Decision Date2019-07-26
Summary:summary

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