K163001 is an FDA 510(k) clearance for the PowerFlow Apheresis I.V. Port. This device is classified as a Subcutaneous Implanted Apheresis Port (Class II - Special Controls, product code PTD).
Submitted by C.R. Bard, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on April 17, 2017, 171 days after receiving the submission on October 28, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5965. 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.
| 510(k) Number | K163001 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 2016 |
| Decision Date | April 17, 2017 |
| Days to Decision | 171 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | PTD — Subcutaneous Implanted Apheresis Port |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5965 |
| Definition | 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 |