510(k) K191143
K191143 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "PowerFlow Implantable Apheresis IV Port". The FDA issued a decision of Substantially Equivalent on August 2, 2019. The device falls under product code PTD (Subcutaneous Implanted Apheresis Port), a Class II device regulated under 21 CFR 880.5965. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 2, 2019
- Date Received
- April 30, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Subcutaneous Implanted Apheresis Port
- Device Class
- Class II
- Regulation Number
- 880.5965
- Review Panel
- HO
- Submission Type
A subcutaneous implanted apheresis port is a prescription device intended for patient therapies requiring repeated access to the vascular system and long-term therapeutic apheresis