K050310 is an FDA 510(k) clearance for the BARDPORT TITANIUM PORTS. This device is classified as a Port & Catheter, Implanted, Subcutaneous, Intravascular (Class II - Special Controls, product code LJT).
Submitted by Bard Access Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on April 18, 2005, 69 days after receiving the submission on February 8, 2005.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5965.
| 510(k) Number | K050310 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 2005 |
| Decision Date | April 18, 2005 |
| Days to Decision | 69 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 |