FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PowerFlow Apheresis I.V. Port
K Number: K163001
·
Decision Apr 17, 2017
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
2
Applicant Total
566
Review Days
171
Basic Information
- Device Name
- PowerFlow Apheresis I.V. Port
- K Number
- K163001
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5965
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- C.R. BARD, INC.
- Date Received
- October 28, 2016
- Decision Date
- April 17, 2017
- Product Code
- PTD
- 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 |
|---|---|---|---|
| PTD | Subcutaneous Implanted Apheresis Port | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PTD), ordered by most recent decision date.
TidalPort-AP Implantable Apheresis Vascular Access Port
FDA 510(k)
FDA Class 2
·General Hospital
PowerFlow Implantable Apheresis IV Port
FDA 510(k)
FDA Class 2
·General Hospital
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