K241058 is an FDA 510(k) clearance for the Lyka® PORT Needle Free Access Device (4170Y). This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Quest Medical, Inc. (Allen, US). The FDA issued a Cleared decision on December 18, 2024, 244 days after receiving the submission on April 18, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K241058 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 18, 2024 |
| Decision Date | December 18, 2024 |
| Days to Decision | 244 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FPA — Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |