FDA.reportPublic FDA data

Artix BG

Primary DI
00850291007321
Brand
Artix BG
Company
Inari Medical, Inc.
Model
30-101
Catalog number
30-101
Device description
Artix BG (65cm)
Published
2023-05-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous
QEWPeripheral Mechanical Thrombectomy With Aspiration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
QEWPeripheral Mechanical Thrombectomy With AspirationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221846000
K223000000
K230912000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221846000Artix Ballon Guiding SheathInari Medical2022-07-11DQY
K223000000Artix BGInari Medical2023-01-11QEW
K230912000Artix BGInari Medical2023-05-02QEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850291007321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850291007321008502910073218502910073210850291007321

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular occluding balloon catheter, image-guidedA flexible tube with an inflatable balloon(s) at the distal end intended to be introduced short-term under image guidance to temporarily block a blood vessel. It may be used for arteriography, selective angiography, preoperative occlusion, peripheral and intracranial vasculature occlusion, emergency control of haemorrhage, to treat malformations (e.g., aneurysms), chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design, one for balloon inflation and another to pass it over a guidewire, or for the infusion of contrast medium, delivery of a smaller catheter, or embolic agents. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-923-4747info@inarimedical.com

Regulatory Flags#

DUNS number
076827459
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810123710249Artix AX31-1012026-01-06
00810123710256Artix AX31-1022026-01-06
00810123710270Intri26 Introducer Sheath52-1022026-01-06
00810123710126InThrill Thrombectomy Catheter43-10243-1022025-05-30
00810123710294InThrill Sheath53-10153-1012025-05-30
00810123710157FlowTriever2 Catheter11-10211-1022025-05-28
00810123710393ClotTriever BOLD Catheter42-1022025-04-09
00850291007352InThrill Thrombectomy Catheter43-10243-1022024-12-20
00850291007697Large Bore 60 cc Syringe99-10299-1022024-12-20
00810123710577Artix Thin-Walled Sheath30-104 / AS-012062024-11-11
00810123710584Artix MT32-102 / AS-012482024-11-11
00810123710591Artix MT32-103 / AS-0124432-1032024-11-11
00810123710560Artix Thin-Walled Sheath30-103 / AS-012162024-11-07
0081012371047816 Fr Evacuation System131-101 / AS-012262024-10-10
0081012371048524 Fr Evacuation System131-102 / AS-012292024-10-10
00850041730165LimFlow Crossing Stent GraftRGS-35060-US-242024-10-08
00850041730172LimFlow Crossing Stent GraftRGS-40060-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

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Primary DI, Brand, Company table
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