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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K201081
Device Name AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter
Applicant
Philips Medical System Nederland B.V.
Veenpluis 4-6
Best,  NL 5684 PC
Applicant Contact Gert De Vries
Correspondent
Philips Medical System Nederland B.V.
Veenpluis 4-6
Best,  NL 5684 PC
Correspondent Contact Gert De Vries
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Codes
DQO   DQX  
Date Received04/22/2020
Decision Date 12/17/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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