FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)
K Number: K241248
·
Decision May 31, 2024
Classifications
1
FEI Numbers
108
Registration Numbers
108
Same Product Code
393
Applicant Total
1
Review Days
28
Basic Information
- Device Name
- Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)
- K Number
- K241248
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.4210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spectrum Medical s.r.l.
- Date Received
- May 3, 2024
- Decision Date
- May 31, 2024
- Product Code
- DWF
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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