CLEARFLOW, INC

FDA Device Registration & Listing · Irvine, CA, US · Registration 3008782989

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008782989
FEI Number
3008782989
Entity Name
CLEARFLOW, INC
City/State/Country
Irvine, CA, US
Establishment Address
16 Technology Drive. Suite 150, Irvine, CA 92618, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
ClearFlow, Inc. (Owner Number: 10034650)
Owner / Operator Contact Address
16 Technology Drive, Suite 150, Irvine, CA 92618, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K163139
PMA Number
N/A

All Registered Proprietary Names

PleuraFlow System with FlowGlide 32FR, PFFG-32 PleuraFlow System with FlowGlide 28FR, PFFG-28 PleuraFlow System with FlowGlide 20FR, PFFG-20 PleuraFlow System with FlowGlide 24FR, PFFG-24

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2017-01-25
OTK Wound Drain Catheter System General, Plastic Surgery Class 2 878.4780 2017-01-25

Official Correspondent

Ken Chesnin

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ClearFlow, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008782989. Last updated year: 2026. Please use registration number 3008782989 when referencing this establishment in official correspondence.
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