FDA.reportPublic FDA data

Protrieve Sheath

Primary DI
00850291007222
Brand
Protrieve Sheath
Company
Inari Medical, Inc.
Model
60-101
Catalog number
60-101
Device description
Protrieve™ Sheath (Sheath)
Published
2023-03-20
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
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
K230331000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230331000Protrieve SheathInari Medical, Inc.2023-03-07QEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850291007222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850291007222008502910072228502910072220850291007222

GMDN Terms#

Term, Definition table
TermDefinition
Thrombectomy wire-net introduction setA dedicated collection of manual invasive devices intended to provide percutaneous vascular access to enable the introduction, and safe retrieval, of a thrombectomy wire-net (not included) during a thrombectomy procedure. It includes a non-steerable sheath typically with an expanding distal funnel to facilitate wire-net retrieval, an obturator/dilator, a haemostatic valve to control blood loss, and a side port. It is typically also designed to allow removal of residual clotted blood, trapped in the sheath funnel upon retrieval, through manual suction (aspiration). 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
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810123710157FlowTriever2 Catheter11-10211-1022025-05-28
00810123710430ClotTriever Sheath, 16 Fr51-101/ AS-0126251-1012023-12-15
00810123710522Triever20 Curve21-201/ AS-0115921-2012023-12-15
00850291007277ClotTriever XL CatheterAS-023541-1022023-05-09
00850291007321Artix BG30-10130-1012023-05-09
00850291007376Artix™ AX31-10131-1012023-04-24
00850291007260Intri24 Introducer Sheath52-10152-1012023-03-20
00850291007239FlowStasis70-1012021-03-22
00850291007017FlowTriever Catheter, M10-1022016-09-15
00850291007048FlowTriever30-1012016-09-15
00850291007055FlowTriever Catheter, XL10-1042016-09-15
00850291007147ClotTriever Catheter, Variable Length41-1022018-05-09
00850041730158LimFlow ARCAC-US-232024-04-19
00850041730011LimFlow ARCAC-US-212023-06-26
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
00810123710393ClotTriever BOLD Catheter42-1022025-04-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885403542667TRUWAVEBecton, Dickinson And CompanyKRA2026-09-05
00885403530534FogartyBecton, Dickinson And CompanyKRA2026-08-14
00885403530541FogartyBecton, Dickinson And CompanyKRA2026-08-14
00885403530558FogartyBecton, Dickinson And CompanyKRA2026-08-14
00885403530572FogartyBecton, Dickinson And CompanyKRA2026-08-14
00885403530589FOGARTYBecton, Dickinson And CompanyKRA2026-08-14
00885403523581VAMPBecton, Dickinson And CompanyKRA2026-07-31
00885403523598VAMPBecton, Dickinson And CompanyKRA2026-07-31
00885403523734VAMPBecton, Dickinson And CompanyKRA2026-07-31
00885403530565FogartyBecton, Dickinson And CompanyKRA2026-07-31
00885403542766TruWave, VAMP PlusBecton, Dickinson And CompanyKRA2026-07-31
00885403522331Swan-GanzBecton, Dickinson And CompanyKRA2026-07-24
00884450825969Fountain®Merit Medical Systems, Inc.KRA2026-06-24
00850013694099MicroGuideMicro Medical Solutions, Inc.KRA2026-04-24
00812339030807Pounce ™ XL ThrombectomySurmodics, Inc.QEW2024-11-13
00812339030760Pounce ™ LP ThrombectomySurmodics, Inc.QEW2024-03-19
00810123710430ClotTriever Sheath, 16 FrInari Medical, Inc.QEW2023-12-15
00810123710522Triever20 CurveInari Medical, Inc.KRA2023-12-15
00810123710522Triever20 CurveInari Medical, Inc.QEW2023-12-15
00812339030319Pounce Venous Thrombectomy SystemSurmodics, Inc.KRA2023-10-27
00812339030319Pounce Venous Thrombectomy SystemSurmodics, Inc.QEW2023-10-27
00812339030784Pounce ™ ThrombectomySurmodics, Inc.QEW2023-08-16
00850291007277ClotTriever XL CatheterInari Medical, Inc.QEW2023-05-09
00850291007277ClotTriever XL CatheterInari Medical, Inc.KRA2023-05-09
00850291007321Artix BGInari Medical, Inc.QEW2023-05-09
00850291007376Artix™ AXInari Medical, Inc.QEW2023-04-24
00850291007376Artix™ AXInari Medical, Inc.KRA2023-04-24
00812339030302Pounce™ Venous Thrombectomy SystemSurmodics, Inc.KRA2022-06-22
00812339030302Pounce™ Venous Thrombectomy SystemSurmodics, Inc.QEW2022-06-22
07640132622690M-CATH FlexyAcrostak (Schweiz) AGKRA2021-11-01