AltaTrack - Angiographic catheter with FORS technology - Philips Medical Systems Nederland B.V.

Duns Number:413819707

Device Description: Angiographic catheter with FORS technology intended to deliver radiopaque media or lead a Angiographic catheter with FORS technology intended to deliver radiopaque media or lead a guidewire in endovascular procedures of the peripheral, aortic and aortic side branch vasculature.

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More Product Details

Catalog Number

ATC55080C2

Brand Name

AltaTrack

Version/Model Number

AltaTrack Catheter Cobra

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

K201081

Product Code Details

Product Code

DQO

Product Code Name

Catheter, Intravascular, Diagnostic

Device Record Status

Public Device Record Key

044c1ad2-5361-406f-b3d7-f3f8118c1ca2

Public Version Date

July 26, 2022

Public Version Number

2

DI Record Publish Date

January 21, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PHILIPS MEDICAL SYSTEMS NEDERLAND B.V." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 349