K133335 is an FDA 510(k) clearance for the POWERPORT IMPLANTABLE PORT. This device is classified as a Port & Catheter, Implanted, Subcutaneous, Intravascular (Class II - Special Controls, product code LJT).
Submitted by C.R. Bard, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on February 14, 2014, 108 days after receiving the submission on October 29, 2013.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5965.
| 510(k) Number | K133335 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 29, 2013 |
| Decision Date | February 14, 2014 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| 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 |