Catalog Number

-

Brand Name

AlphaVac

Version/Model Number

25-301

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"

-

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

K211081

Product Code

QEZ

Product Code Name

Aspiration thrombectomy catheter

Public Device Record Key

dd7a7a77-5aca-4997-b823-d0d1d4a1e438

Public Version Date

August 05, 2022

Public Version Number

2

DI Record Publish Date

July 07, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-