FDA.reportPublic FDA data

Artix AX

Primary DI
00850291007376
Brand
Artix AX
Company
Inari Medical, Inc.
Model
31-101
Catalog number
31-101
Device description
Artix AX Aspiration Catheter, 8Fr, 85cm
Published
2023-04-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRACatheter, Continuous Flush
QEWPeripheral Mechanical Thrombectomy With Aspiration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRACatheter, Continuous FlushCardiovascular2
QEWPeripheral Mechanical Thrombectomy With AspirationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223436000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223436000Artix AXInari Medical2023-03-02QEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850291007376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850291007376008502910073768502910073760850291007376

GMDN Terms#

Term, Definition table
TermDefinition
Thrombectomy suction catheterA flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
18779234747info@inarimedical.com

Regulatory Flags#

DUNS number
076827459
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850041730141LimFlow V-CeiverVC-US-232024-03-09
00850041730165LimFlow Crossing Stent GraftRGS-35060-US-242024-10-08
00850041730189LimFlow Extension Stent GraftRGS-55060-US-242024-10-08
00850041730196LimFlow Extension Stent GraftRGS-55100-US-242024-10-08
00850041730202LimFlow Extension Stent GraftRGS-55150-US-242024-10-08
00810123710140ClotTriever Catheter40-10240-1022024-04-17
00850291007475Triever LA Transseptal Sheath121-101121-1012024-04-15
00850041730134LimFlow VectorVT-US-232024-04-12
00810123710058ClotTriever SheathAS-0126150-1012023-12-15
00810123710430ClotTriever Sheath51-10151-1012023-12-15
00850291007123ClotTriever Sheath51-1012021-03-22
00850041730158LimFlow ARCAC-US-23AC-US-232024-04-19
00850291007697Large Bore 60 cc Syringe99-10299-1022024-12-20
00810123710577Artix Thin-Walled Sheath30-1042024-11-11
00810123710560Artix Thin-Walled Sheath30-10330-1032024-11-07
00850291007406VenaCore Thrombectomy Catheter46-10146-1012024-03-27
00850291007420FlowStasis Single-Pack70-10370-1032023-07-19
00850291007369InThrill Sheath53-10153-1012023-07-18
00850291007246FlowSaver80-10180-1012023-05-09
00850291007277ClotTriever XL Catheter41-10241-1022023-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009303423Powered Aventus Clot Management SystemInquis Medical, Inc.KRA2026-10-19
00860009303461C02 Cartridge AccessoryInquis Medical, Inc.KRA2026-10-19
00860009303492Powered Aventus Thrombectomy Catheter, 16F, 115cmInquis Medical, Inc.KRA2026-10-19
00860014559259C02 Cartridge Accessory - 5 PackInquis Medical, Inc.KRA2026-10-19
00860014559273Powered Aventus Thrombectomy CatheterInquis Medical, Inc.KRA2026-10-19
05391547390019InVera Infusion DeviceINVERA MEDICAL LIMITEDKRA2026-10-09
00850044140022Helo Max Thrombectomy SystemEndovascular Engineering, Inc.KRA2026-09-29
00850044140022Helo Max Thrombectomy SystemEndovascular Engineering, Inc.QEW2026-09-29
00857136004293TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00857136004392TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00857136004408TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00857136004415TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00885403542667TRUWAVEBecton, Dickinson And CompanyKRA2026-09-05
00810123710126InThrill Thrombectomy CatheterInari Medical, Inc.QEW2025-05-30
00810123710393ClotTriever BOLD CatheterInari Medical, Inc.KRA2025-04-09
00810123710393ClotTriever BOLD CatheterInari Medical, Inc.QEW2025-04-09
00850291007697Large Bore 60 cc SyringeInari Medical, Inc.QEW2024-12-20
00812339030807Pounce ™ XL ThrombectomySurmodics, Inc.QEW2024-11-13
00810123710577Artix Thin-Walled SheathInari Medical, Inc.KRA2024-11-11
00810123710560Artix Thin-Walled SheathInari Medical, Inc.KRA2024-11-07
B0902P0130B0Knight MicrocatheterZien Medical Technologies, LLCKRA2024-04-30
B0902P0130S0Knight MicrocatheterZien Medical Technologies, LLCKRA2024-04-30
B090E20130B0XO CathZien Medical Technologies, LLCKRA2024-04-30
B090E20130S0XO CathZien Medical Technologies, LLCKRA2024-04-30
00810123710140ClotTriever CatheterInari Medical, Inc.KRA2024-04-17
00810123710140ClotTriever CatheterInari Medical, Inc.QEW2024-04-17
00850291007406VenaCore Thrombectomy CatheterInari Medical, Inc.QEW2024-03-27
00850291007406VenaCore Thrombectomy CatheterInari Medical, Inc.KRA2024-03-27
00812339030760Pounce ™ LP ThrombectomySurmodics, Inc.QEW2024-03-19
00810123710058ClotTriever SheathInari Medical, Inc.QEW2023-12-15