ClotTriever Sheath, 13 Fr

Basic Information

• Brand Name: ClotTriever Sheath, 13 Fr
• Primary DI: 00810123710058
• Version / Model: AS-01261/ 50-101
• Catalog Number: 50-101
• Company Name: INARI MEDICAL INC
• Labeler DUNS: 076827459
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-15
• Public Version: 1
• Public Version Date: 2023-12-25
• Public Version Status: New
• Public Device Record Key: 7773cdd5-059a-499d-b226-fb619adf2908

Device Description

ClotTriever Sheath, 13 Fr (ClotTriever Thrombectomy System)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	870.5150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66423	Thrombectomy wire-net introduction set	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810123710058	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K210689	000