The following data is part of a premarket notification filed by Philips Medical System Nederland B.v. with the FDA for Altatrack Equipment, Altatrack Guidewire, Altatrack Catheter.
| Device ID | K201081 |
| 510k Number | K201081 |
| Device Name: | AltaTrack Equipment, AltaTrack Guidewire, AltaTrack Catheter |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | Philips Medical System Nederland B.V. Veenpluis 4-6 Best, NL 5684 Pc |
| Contact | Gert De Vries |
| Correspondent | Gert De Vries Philips Medical System Nederland B.V. Veenpluis 4-6 Best, NL 5684 Pc |
| Product Code | DQK |
| Subsequent Product Code | DQO |
| Subsequent Product Code | DQX |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-22 |
| Decision Date | 2020-12-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838099340 | K201081 | 000 |
| 00884838070974 | K201081 | 000 |
| 00884838070967 | K201081 | 000 |
| 00884838070950 | K201081 | 000 |