K223918 is an FDA 510(k) clearance for the AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub. This device is classified as 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 FDA review panel. Regulated under 21 CFR 870.1425.
| 510(k) Number | K223918 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | DQK — Computer, Diagnostic, Programmable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1425 |