FDA.reportPublic FDA data

ClotTriever Sheath, 13 Fr

Primary DI
00850291007109
Brand
ClotTriever Sheath, 13 Fr
Company
Inari Medical, Inc.
Model
50-101
Catalog number
50-101
Device description
ClotTriever Sheath, 13Fr, 15cm
Published
2017-04-19
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
DXECatheter, Embolectomy
DYBIntroducer, Catheter
KRACatheter, Continuous Flush
QEWPeripheral Mechanical Thrombectomy With Aspiration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXECatheter, EmbolectomyCardiovascular2
DYBIntroducer, CatheterCardiovascular2
KRACatheter, Continuous FlushCardiovascular2
QEWPeripheral Mechanical Thrombectomy With AspirationCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850291007109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850291007109008502910071098502910071090850291007109

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Outer Diameter0

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
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
00810123710430ClotTriever Sheath, 16 Fr51-101/ AS-0126251-1012023-12-15
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
00850291007376Artix AX31-10131-1012023-04-24
00850291007222Protrieve Sheath60-10160-1012023-03-20
00850291007260Intri24 Introducer Sheath52-10152-1012023-03-20
00850291007239FlowStasis70-10170-1012021-03-22
00850291007253FlowStasis70-10270-1022021-03-22
00850291007000FlowTriever Catheter10-10110-1012016-09-15
00850291007017FlowTriever Catheter10-10210-1022016-09-15
00850291007024FlowTriever Catheter10-10310-1032016-09-15
00850291007055FlowTriever Catheter10-10410-1042016-09-15
00810123710126InThrill Thrombectomy Catheter43-10243-1022025-05-30
00810123710393ClotTriever BOLD Catheter42-10242-1022025-04-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884450438791Prelude® Short SheathMerit Medical Systems, Inc.DYB2026-10-06
00850044140022Helo Max Thrombectomy SystemEndovascular Engineering, Inc.QEW2026-09-29
00850044140022Helo Max Thrombectomy SystemEndovascular Engineering, Inc.KRA2026-09-29
10884450119751Prelude EASE™Merit Medical Systems, Inc.DYB2026-09-29
10884450439163Prelude IDeal™Merit Medical Systems, Inc.DYB2026-09-29
10884450439187Prelude IDeal™Merit Medical Systems, Inc.DYB2026-09-29
10801902226188ARROWTELEFLEX INCORPORATEDDYB2026-09-28
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
10801902228700ARROWTELEFLEX INCORPORATEDDYB2026-09-22
10884450489809Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489816Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489823Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489830Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489847Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489854Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489861Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489878Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489885Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489892Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489908Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489915Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489922Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489939Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489946Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489953Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489960Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489977Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22