Catalog Number

PV-12-40-HELIX

Brand Name

CONCERTO

Version/Model Number

PV-12-40-HELIX

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K090046

Product Code

KRD

Product Code Name

Device, Vascular, for Promoting Embolization

Public Device Record Key

0187e9ac-0de1-4c04-a100-719f1bda2a5b

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

October 16, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-