FDA.reportPublic FDA data

CLEARFLOW, INC

Matched from indexed company URL: CLEARFLOW, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30087829893008782989CLEARFLOW, INC1N2026-01-0116 Technology Drive. Suite 150 Irvine CA US 92618
30278728433027872843ClearFlow Distribution Company1Y2026-01-0116 Technology Drive Suite 150 Irvine CA US 92618

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00856449006017PleuraFlow® System - PF-24 PleuraFlow® System844-257-3569customerservice@clearflow.com
00856449006024PleuraFlow® System - PF-28 PleuraFlow® System844-257-3569customerservice@clearflow.com
00856449006048PleuraFlow® System with FlowGlide - PF-20 SEDL PleuraFlow® System with FlowGlide844-257-3569customerservice@clearflow.com
00856449006055PleuraFlow® System with FlowGlide - PFFG-20 PleuraFlow® System with FlowGlide™844-257-3569customerservice@clearflow.com
00856449006062PleuraFlow® System with FlowGlide - PFFG-24 PleuraFlow® System with FlowGlide™844-257-3569customerservice@clearflow.com
00856449006079PleuraFlow® System with FlowGlide - PFFG-28 PleuraFlow® System with FlowGlide™844-257-3569customerservice@clearflow.com
00856449006086PleuraFlow® System with FlowGlide - PFFG-32 PleuraFlow® System with FlowGlide™844-257-3569customerservice@clearflow.com
00856449006161PleuraFlow® ZIP - The ZIP, Accessory Shuttle for PleuraFlow® System844-257-3569customerservice@clearflow.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1241871142739023K203394PleuraFlow System with FlowGlideOTK2021-03-02
1241871968880874K182067PleuraFlow System with FlowGlide Extra Drainage LengthOTK2018-08-14
1241871992497012K163139PleuraFlow System with FlowGlideOTK2016-11-30
1241871709936486K153681PleuraFlow SystemOTK2016-01-20
1241871559177780K093565PLEURAFLOW CATHETER SYSTEMOTK2010-12-03
1241871051517521

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OTK52021-03-02

PMN#

GUDID#

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