ClotTriever BOLD Catheter

Basic Information

• Brand Name: ClotTriever BOLD Catheter
• Primary DI: 00850291007314
• Version / Model: 42-102
• Company Name: INARI MEDICAL INC
• Labeler DUNS: 076827459
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-15
• Public Version: 4
• Public Version Date: 2023-07-20
• Public Version Status: Update
• Public Device Record Key: 7e21468c-83d9-414d-b758-9f5a0dc4628e

Device Description

ClotTriever BOLD Catheter (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
KRA	Catheter, Continuous Flush	Cardiovascular	870.1210	2
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	870.5150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61779	Thrombectomy wire-net	A device intended to be percutaneously introduced into the vasculature (coronary, peripheral and/or intracranial) through an appropriate intravascular catheter for the removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction; revascularization may also be achieved through thrombus reorientation. Also referred to as a stent retriever or clot retrieval catheter, it consists of an expanding, stent-like wire net connected to a pusher wire primarily intended to grip and remove the emboli/thrombi; it might include a guide-catheter dedicated to introduction of the wire-net. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850291007314	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K212632	000
K230494	000