Catalog Number

4002C1135

Brand Name

Penumbra Coil 400

Version/Model Number

4002C1135-A

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K173614

Product Code

HCG

Product Code Name

DEVICE, NEUROVASCULAR EMBOLIZATION

Public Device Record Key

facbd04f-ca64-4a4d-8fd4-56a92e7fedc2

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

May 16, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-