Advocate - Advocate 0.018" PTA Catheter (3.0mm x 80mm x - ARRAVASC LIMITED

Duns Number:896165250

Device Description: Advocate 0.018" PTA Catheter (3.0mm x 80mm x 1500mm)

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More Product Details

Catalog Number

-

Brand Name

Advocate

Version/Model Number

A18030080150

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K151153

Product Code Details

Product Code

LIT

Product Code Name

Catheter, Angioplasty, Peripheral, Transluminal

Device Record Status

Public Device Record Key

e83caad2-2d2c-47c3-ab0e-85349ee3cf04

Public Version Date

August 09, 2019

Public Version Number

4

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ARRAVASC LIMITED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 442