Catalog Number

AP11016P

Brand Name

Adelante Peel-Away Introducer Set

Version/Model Number

AP11016P

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

K073100,K073100

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

b54f629c-b6b0-4617-993c-d1f247c4b845

Public Version Date

June 07, 2019

Public Version Number

4

DI Record Publish Date

November 15, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-