K232737 is an FDA 510(k) clearance for the PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port. This device is classified as a Port & Catheter, Implanted, Subcutaneous, Intravascular (Class II - Special Controls, product code LJT).
Submitted by Bard Peripheral Vascular, Inc. (Tempe, US). The FDA issued a Cleared decision on December 8, 2023, 92 days after receiving the submission on September 7, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5965.
| 510(k) Number | K232737 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 2023 |
| Decision Date | December 08, 2023 |
| Days to Decision | 92 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LJT — Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5965 |