AltaTrack Catheter ATC55080C2

GUDID 00884838070967

The AltaTrack Catheter is a single-use, sterile, angiographic catheter with FORS technology. Its primary function is to deliver radiopaque media or lead an AltaTrack Guidewire or other compatible guidewire to a desired anatomical location. It can be visualized in 3D in real time by the AltaTrack equipment using FORS technology

Philips Medical Systems Nederland B.V.

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• Primary Device ID: 00884838070967
• NIH Device Record Key: 044c1ad2-5361-406f-b3d7-f3f8118c1ca2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AltaTrack Catheter
• Version Model Number: 43220701346
• Catalog Number: ATC55080C2
• Company DUNS: 413819707
• Company Name: Philips Medical Systems Nederland B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838070967 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201081

FDA Product Code

• DQO: Catheter, Intravascular, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-29
• Device Publish Date: 2021-01-21

On-Brand Devices [AltaTrack Catheter]

• 00884838070967: The AltaTrack Catheter is a single-use, sterile, angiographic catheter with FORS technology. Its
• 00884838070950: The AltaTrack Catheter is a single-use, sterile, angiographic catheter with FORS technology. Its