AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub
FDA 510(k) K223918 · Philips Medical Systems Nederland B.V.
510(k) numberK223918
Submission
- Device name
- AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub
- Applicant
- Philips Medical Systems Nederland B.V.
Best, NL - Received
- December 29, 2022
- Decision date
- June 8, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQK – Computer, Diagnostic, Programmable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1425
- Specialty
- Cardiovascular
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Questions and answers
When was AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub cleared by the FDA?
AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub (K223918) received a 510(k) decision of Substantially Equivalent on June 8, 2023, 161 days after the submission was received.
What is the product code of K223918?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.