ICHOR

GUDID B729ICH7FR0

The ICHOR embolectomy system is indicated for the non-surgical removal of emboli and thrombi from blood vessels. The device is intended for the peripheral vasculature.

ICHOR VASCULAR, INC.

Thrombectomy balloon catheter

• Primary Device ID: B729ICH7FR0
• NIH Device Record Key: aee1b6ed-9018-427e-8226-8c02dfa705f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ICHOR
• Version Model Number: ICH7FR
• Company DUNS: 074702488
• Company Name: ICHOR VASCULAR, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B729ICH7FR0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182167

FDA Product Code

• DXE: Catheter, Embolectomy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-10-24
• Device Publish Date: 2019-07-31

On-Brand Devices [ICHOR]

• B729ICH7FR0: The ICHOR embolectomy system is indicated for the non-surgical removal of emboli and thrombi fro
• 00860010378007: The ICHOR embolectomy system is indicated for the non-surgical removal of emboli and thrombi fro