Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)— 510(k) K241248
Substantially EquivalentSpectrum Medical S.R.L.
FDA 510(k) clearance K241248 for Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1), Substantially Equivalent on 2024-05-31. Applicant: Spectrum Medical S.R.L.. Device class: 2.
Clearance details
- Applicant
- Spectrum Medical S.R.L.
- Product code
- Code DWF
- Device class
- Class 2
- Regulation
- 21 CFR 870.4210
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mirandola, IT
Recent devices under product code DWF
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- K241206 — Quantum Perfusion Hybrid System
Adverse events under product code DWF
product code DWF- Death
- 106
- Injury
- 386
- Malfunction
- 2,323
- Total
- 2,815
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.