Inari Medical, Inc.

FDA Device Registration & Listing · Irvine, CA, US · Registration 3020347218

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
3020347218
FEI Number
3020347218
Entity Name
Inari Medical, Inc.
City/State/Country
Irvine, CA, US
Establishment Address
6001 Oak Canyon, Suite 100, Irvine, CA 92618, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
STRYKER CORP. (Owner Number: 1811755)
Owner / Operator Contact Address
4100 East Milham Ave., Kalamazoo, MI 49001, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K231782
PMA Number
N/A

All Registered Proprietary Names

ClotTriever BOLD Catheter Large Bore Syringe, 60 cc, 3-pack Large Bore Syringe, 60 cc Artix BG FlowTriever2 Catheter VenaCore Thrombectomy Catheter ClotTriever XL Catheter ClotTriever Thrombectomy system Protrieve Sheath ClotTriever Sheath RevCoreTM Thrombectomy Catheter Large Bore Syringe, 60 cc, 3-Pack Triever Catheters Triever24 FlowTriever Retrieval/Aspiration System Large Bore Syringe, 60 cc Triever20 Artix MT Artix Thin-Walled Thrombectomy Sheath Large Bore Syringe, 60 cc FlowSaver Blood Return System Large Bore Syringe, 60 cc, 3-pack ClotTriever Sheath 16 Fr ClotTriever Pre-Dilator 19 Fr ClotTriever Pre-Dilator,16 Fr ClotTriever Sheath 13Fr ClotTriever Catheter ClotTriever Thrombectomy System Protrieve Sheath ClotTriever Thrombectomy System ClotTriever Sheath, 16Fr ClotTriever Sheath, 13Fr ClotTriever Catheter Large Bore Syringe, 60 cc, 3-Pack ClotTriever Sheath Large Bore Syringe, 60 cc Large Bore Syringe, 60 cc, 3-pack FlowSaver FlowSaver Blood Return System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-03-10
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-03-10
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-03-10
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-03-10
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-03-25
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-03-25
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-03-10
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-03-10
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-03-10
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-03-10
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-03-10
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-03-10
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-03-10
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-03-10
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-03-10
CAC Apparatus, Autotransfusion Anesthesiology Class 2 868.5830 2025-03-10
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-03-10
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2025-12-08
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-12-08
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-12-08
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-03-10
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-03-10
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2025-03-10
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-03-10
CAC Apparatus, Autotransfusion Anesthesiology Class 2 868.5830 2025-03-10

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Other Registrations for Same Entity

Registration Number Establishment Name Location
3003897776 BIOMIMETIC THERAPEUTICS,LLC FRANKLIN, TN, US
3040801290 Inari Medical, Costa Rica S.A. Grecia Alajuela, CR
2031049 TMJ Solutions, LLC San Buenaventura, CA, US
3016573902 Ortho-Space Ltd. Caesarea Haifa, IL
3010411911 POM Medical, LLC Moorpark, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K250421 Inari Medical, Inc. InThrill™ Thrombectomy System 2025-05-12
K241362 Surmodics,Inc. Pounce XL Thrombectomy System (PTS-1011-7F135) 2024-09-11
K220887 Inari Medical Mini-ClotTriever Thrombectomy System 2022-08-04
K192036 Inari Medical ClotTriever Thrombectomy System 2019-08-29
K792141 Pharmaseal Div., Baxter Healthcare Corp. CONTINUOUS FLUSH DEVICE 1979-12-05

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2010 Penumbra Inc. 2
Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014 Cordis Corporation 2
Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-04 Bard Peripheral Vascular 2
Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124
Z-0010-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020347218. Last updated year: 2026. Please use registration number 3020347218 when referencing this establishment in official correspondence.
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