AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub— 510(k) K223918
Substantially EquivalentPhilips Medical Systems Nederland B.V.
FDA 510(k) clearance K223918 for AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub, Substantially Equivalent on 2023-06-08. Applicant: Philips Medical Systems Nederland B.V.. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems Nederland B.V.
- Product code
- Code DQK
- Device class
- Class 2
- Regulation
- 21 CFR 870.1425
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Best, NL
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Adverse events under product code DQK
product code DQK- Death
- 10
- Injury
- 225
- Malfunction
- 2,123
- Other
- 2
- Total
- 2,360
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.