FlowTriever Catheter, S

GUDID 00850291007000

FlowTriever Catheter, S

INARI MEDICAL INC

Thrombectomy suction catheter
Primary Device ID00850291007000
NIH Device Record Keyada26eaf-fc84-4391-b1e9-cb31df05f2f3
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlowTriever Catheter, S
Version Model Number10-101
Company DUNS076827459
Company NameINARI MEDICAL INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone19496008433
Emailinfo@inarimedical.com
Phone19496008433
Emailinfo@inarimedical.com
Phone19496008433
Emailinfo@inarimedical.com
Phone19496008433
Emailinfo@inarimedical.com
Phone19496008433
Emailinfo@inarimedical.com
Phone19496008433
Emailinfo@inarimedical.com
Phone19496008433
Emailinfo@inarimedical.com
Phone19496008433
Emailinfo@inarimedical.com
Phone19496008433
Emailinfo@inarimedical.com
Phone19496008433
Emailinfo@inarimedical.com
Phone19496008433
Emailinfo@inarimedical.com
Phone19496008433
Emailinfo@inarimedical.com
Phone19496008433
Emailinfo@inarimedical.com
Phone19496008433
Emailinfo@inarimedical.com
Phone19496008433
Emailinfo@inarimedical.com
Phone19496008433
Emailinfo@inarimedical.com
Phone19496008433
Emailinfo@inarimedical.com
Phone19496008433
Emailinfo@inarimedical.com
Phone19496008433
Emailinfo@inarimedical.com
Phone19496008433
Emailinfo@inarimedical.com
Phone19496008433
Emailinfo@inarimedical.com
Phone19496008433
Emailinfo@inarimedical.com
Phone19496008433
Emailinfo@inarimedical.com
Phone19496008433
Emailinfo@inarimedical.com
Phone19496008433
Emailinfo@inarimedical.com
Phone19496008433
Emailinfo@inarimedical.com
Phone19496008433
Emailinfo@inarimedical.com

Device Dimensions

Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850291007000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXECatheter, Embolectomy
QEWPeripheral Mechanical Thrombectomy With Aspiration

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-04
Device Publish Date2016-09-15

Devices Manufactured by INARI MEDICAL INC

00810123710126 - InThrill Thrombectomy Catheter2025-06-09 InThrill Thrombectomy Catheter (AS-01312)
00810123710294 - InThrill Sheath2025-06-09 InThrill Sheath (AS-01403)
00810123710157 - FlowTriever2 Catheter2025-06-05 FlowTriever2 Catheter (AS-01397)
00810123710393 - ClotTriever BOLD Catheter2025-04-17 ClotTriever BOLD Catheter
00850291007352 - InThrill Thrombectomy Catheter2024-12-30 InThrill Thrombectomy Catheter
00850291007697 - Large Bore 60 cc Syringe2024-12-30 Large Bore 60 cc Syringe
00810123710577 - Artix Thin-Walled Sheath2024-11-19 Artix Thin-Walled Sheath
00810123710584 - Artix MT2024-11-19 Artix MT (Thrombectomy Device)
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