K243941 is an FDA 510(k) clearance for the HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201). 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 January 17, 2025, 28 days after receiving the submission on December 20, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K243941 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2024 |
| Decision Date | January 17, 2025 |
| Days to Decision | 28 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 |