AccessGUDID - DEVICE: ICHOR (00860010378007)

GUDID

Device Identifier (DI) Information

Brand Name: ICHOR
Version or Model: ICH14FR
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ICHOR VASCULAR, INC.

Primary DI Number: 00860010378007
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 074702488 *Terms of Use

Device Description: 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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58174	Thrombectomy balloon catheter	A flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) causing vascular obstruction in native and stented blood vessels, native and synthetic bypass grafts, and/or haemodialysis access grafts, through distension of a balloon intended to dilate the stenosis. It is a balloon catheter that may include valves for the injection of contrast media/thrombolytic agents and/or an embolectomy coil for mechanical removal of the obstruction. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXE	Catheter, Embolectomy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K230743	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 70 and 75 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 14F French

Device Record Status

Public Device Record Key: 85f68a0d-c9ed-477c-81b2-57d77bccbeee
Public Version Date: October 21, 2024
Public Version Number: 2
DI Record Publish Date: October 13, 2023