K191143 is an FDA 510(k) clearance for the PowerFlow Implantable Apheresis IV 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 August 2, 2019, 94 days after receiving the submission on April 30, 2019.
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 | K191143 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2019 |
| Decision Date | August 02, 2019 |
| Days to Decision | 94 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 |