Catalog Number

AC10SH085

Brand Name

QuickClear Aspiration Catheter, 10F x 85cm Shaped

Version/Model Number

AC10SH085

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

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

K193197

Product Code

QEZ

Product Code Name

Aspiration Thrombectomy Catheter

Public Device Record Key

6db53092-d6d6-4f39-b52c-c9fa8f924062

Public Version Date

August 05, 2022

Public Version Number

5

DI Record Publish Date

June 11, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-