K093414 is an FDA 510(k) clearance for the PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS. This device is classified as a Port & Catheter, Implanted, Subcutaneous, Intravascular (Class II - Special Controls, product code LJT).
Submitted by Smiths Medical Asd, Inc. (St. Paul, US). The FDA issued a Cleared decision on March 1, 2010, 119 days after receiving the submission on November 2, 2009.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5965.
| 510(k) Number | K093414 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 2009 |
| Decision Date | March 01, 2010 |
| Days to Decision | 119 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 |