K021580 is an FDA 510(k) clearance for the OPTILOCK IMPLANTABLE ACCESS PORT, MODELS #1700-01, 1700-02, 1700-03, 1700-04 AND 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 February 12, 2003, 274 days after receiving the submission on May 14, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5965.
| 510(k) Number | K021580 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 2002 |
| Decision Date | February 12, 2003 |
| Days to Decision | 274 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 |