FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PowerPort ClearVUE Slim ECG Enabled Implantable Port; PowerPort ClearVUE isp ECG Enabled Implantable Port; PowerPort isp M.R.I. ECG Enabled Implantable Port; PowerPort Slim ECG Enabled Implantable Port
K Number: K232737
·
Decision Dec 8, 2023
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
287
Applicant Total
34
Review Days
92
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Basic Information
- Device Name
- PowerPort ClearVUE Slim ECG Enabled Implantable Port; PowerPort ClearVUE isp ECG Enabled Implantable Port; PowerPort isp M.R.I. ECG Enabled Implantable Port; PowerPort Slim ECG Enabled Implantable Port
- K Number
- K232737
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5965
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bard Peripheral Vascular, Inc.
- Date Received
- September 7, 2023
- Decision Date
- December 8, 2023
- Product Code
- LJT
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LJT), ordered by most recent decision date.
FLEXI-PORT Power Injectable Implantable Port
FDA 510(k)
FDA Class 2
·General Hospital
Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable Implantable Port; PowerPort duo M.R.I. Implantable Port
FDA 510(k)
FDA Class 2
·General Hospital
PowerPort isp Implantable Port; PowerPort Slim Implantable Port; PowerPort M.R.I. Implantable Port; PowerPort M.R.I. isp Implantable Port
FDA 510(k)
FDA Class 2
·General Hospital
PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports
FDA 510(k)
FDA Class 2
·General Hospital
SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports
FDA 510(k)
FDA Class 2
·General Hospital
Bard Power-Injectable Implantable Ports (PowerPorts®)
FDA 510(k)
FDA Class 2
·General Hospital
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