Cleared Abbreviated

AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub

K223918 · Philips Medical Systems Nederland B.V. · Cardiovascular
Jun 2023
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K223918 is an FDA 510(k) clearance for the AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Philips Medical Systems Nederland B.V. (Best, NL). The FDA issued a Cleared decision on June 8, 2023, 161 days after receiving the submission on December 29, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K223918 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 2022
Decision Date June 08, 2023
Days to Decision 161 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQK — Computer, Diagnostic, Programmable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1425

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