FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)
K Number: K240908
·
Decision Jul 8, 2025
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
90
Applicant Total
15
Review Days
462
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Basic Information
- Device Name
- Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)
- K Number
- K240908
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4240
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spectrum Medical , Ltd.
- Date Received
- April 2, 2024
- Decision Date
- July 8, 2025
- Product Code
- DTR
- 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 |
|---|---|---|---|
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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