ICHOR - The ICHOR embolectomy system is indicated for the - ICHOR VASCULAR, INC.

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.

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More Product Details

Catalog Number

-

Brand Name

ICHOR

Version/Model Number

ICH7FR

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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 Details

Product Code

DXE

Product Code Name

Catheter, Embolectomy

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ICHOR VASCULAR, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1