Catalog Number

E 01 3506

Brand Name

VenSure Balloon Sinus Dilation System

Version/Model Number

1

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

K201472,K201472

Product Code

LRC

Product Code Name

Instrument, Ent Manual Surgical

Public Device Record Key

bf772b6f-9f6f-4b3f-98ec-2626d8fdd751

Public Version Date

October 25, 2022

Public Version Number

3

DI Record Publish Date

June 11, 2021

Package DI Number

EFIAE0135062

Quantity per Package

5

Contains DI Package

EFIAE0135061

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-