Catalog Number

-

Brand Name

Venclose Maven Catheter

Version/Model Number

VC-0.5-6F

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K211806,K211806,K211806

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

6631a424-009a-4f6b-94c9-7d19fa8d994d

Public Version Date

September 09, 2021

Public Version Number

1

DI Record Publish Date

September 01, 2021

Package DI Number

00858254006404

Quantity per Package

5

Contains DI Package

00858254006398

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box