K031282 is an FDA 510(k) clearance for the OPTILOCK IMPLANTABLE ACCESS PORT, MODEL 1700-05. This device is classified as a Port & Catheter, Implanted, Subcutaneous, Intravascular (Class II - Special Controls, product code LJT).
Submitted by LeMaitre Vascular, Inc. (Burlington, US). The FDA issued a Cleared decision on August 5, 2003, 105 days after receiving the submission on April 22, 2003.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5965.
| 510(k) Number | K031282 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 2003 |
| Decision Date | August 05, 2003 |
| Days to Decision | 105 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 |