LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub— 510(k) K252645
Substantially EquivalentPhilips Medical Systems Nederland B.V.
FDA 510(k) clearance K252645 for LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub, Substantially Equivalent on 2025-10-24. 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.