K120281 is an FDA 510(k) clearance for the DIGNITY POWER INJECTABLE TITANIUM PORT. This device is classified as a Port & Catheter, Implanted, Subcutaneous, Intravascular (Class II - Special Controls, product code LJT).
Submitted by Medical Components, Inc. (Harleysville, US). The FDA issued a Cleared decision on September 17, 2012, 230 days after receiving the submission on January 31, 2012.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5965.
| 510(k) Number | K120281 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 2012 |
| Decision Date | September 17, 2012 |
| Days to Decision | 230 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 |