K251212 is an FDA 510(k) clearance for the Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM). This device is classified as a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II - Special Controls, product code LJS).
Submitted by Access Vascular, Inc. (Ballerica, US). The FDA issued a Cleared decision on July 1, 2025, 74 days after receiving the submission on April 18, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K251212 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 18, 2025 |
| Decision Date | July 01, 2025 |
| Days to Decision | 74 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LJS - Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5970 |