ICHOR

GUDID 00860010378007

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

ICHOR VASCULAR, INC.

Thrombectomy balloon catheter

• Primary Device ID: 00860010378007
• NIH Device Record Key: 85f68a0d-c9ed-477c-81b2-57d77bccbeee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ICHOR
• Version Model Number: ICH14FR
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9544834525
• Email: tblair34@gmail.com
• Phone: 9544834525
• Email: tblair34@gmail.com
• Phone: 9544834525
• Email: tblair34@gmail.com
• Phone: 9544834525
• Email: tblair34@gmail.com
• Phone: 9544834525
• Email: tblair34@gmail.com
• Phone: 9544834525
• Email: tblair34@gmail.com
• Phone: 9544834525
• Email: tblair34@gmail.com
• Phone: 9544834525
• Email: tblair34@gmail.com
• Phone: 9544834525
• Email: tblair34@gmail.com
• Phone: 9544834525
• Email: tblair34@gmail.com
• Phone: 9544834525
• Email: tblair34@gmail.com
• Phone: 9544834525
• Email: tblair34@gmail.com
• Phone: 9544834525
• Email: tblair34@gmail.com
• Phone: 9544834525
• Email: tblair34@gmail.com
• Phone: 9544834525
• Email: tblair34@gmail.com
• Phone: 9544834525
• Email: tblair34@gmail.com
• Phone: 9544834525
• Email: tblair34@gmail.com
• Phone: 9544834525
• Email: tblair34@gmail.com
• Phone: 9544834525
• Email: tblair34@gmail.com
• Phone: 9544834525
• Email: tblair34@gmail.com
• Phone: 9544834525
• Email: tblair34@gmail.com
• Phone: 9544834525
• Email: tblair34@gmail.com
• Phone: 9544834525
• Email: tblair34@gmail.com
• Phone: 9544834525
• Email: tblair34@gmail.com
• Phone: 9544834525
• Email: tblair34@gmail.com
• Phone: 9544834525
• Email: tblair34@gmail.com
• Phone: 9544834525
• Email: tblair34@gmail.com
• Phone: 9544834525
• Email: tblair34@gmail.com
• Phone: 9544834525
• Email: tblair34@gmail.com
• Phone: 9544834525
• Email: tblair34@gmail.com
• Phone: 9544834525
• Email: tblair34@gmail.com
• Phone: 9544834525
• Email: tblair34@gmail.com
• Phone: 9544834525
• Email: tblair34@gmail.com

Device Dimensions

• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French

Operating and Storage Conditions

• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 75 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010378007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230743

FDA Product Code

• DXE: Catheter, Embolectomy

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-23
• Device Publish Date: 2023-10-13

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