FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SMARxT Tubing and Connectors
K Number: K233702
·
Decision Aug 8, 2024
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
20
Applicant Total
3
Review Days
265
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Basic Information
- Device Name
- SMARxT Tubing and Connectors
- K Number
- K233702
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4390
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- LivaNova USA, Inc.
- Date Received
- November 17, 2023
- Decision Date
- August 8, 2024
- Product Code
- DWE
- 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 |
|---|---|---|---|
| DWE | Tubing, Pump, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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