K130923 is an FDA 510(k) clearance for the 5F DIGNITY CT 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 July 31, 2013, 119 days after receiving the submission on April 3, 2013.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5965.
| 510(k) Number | K130923 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 2013 |
| Decision Date | July 31, 2013 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | LJT — Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5965 |