Duns Number:074702488
Device Description: The ICHOR embolectomy system is indicated for the non-surgical removal of emboli and throm 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.
Catalog Number
-
Brand Name
ICHOR
Version/Model Number
ICH7FR
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K182167
Product Code
DXE
Product Code Name
Catheter, Embolectomy
Public Device Record Key
aee1b6ed-9018-427e-8226-8c02dfa705f9
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
July 31, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |