K243484 is an FDA 510(k) clearance for the PM2+ System and SmartPICC Stylet. This device is classified as a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II - Special Controls, product code LJS).
Submitted by Piccolo Medical, Inc. (San Francisco, US). The FDA issued a Cleared decision on May 29, 2025, 202 days after receiving the submission on November 8, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K243484 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2024 |
| Decision Date | May 29, 2025 |
| Days to Decision | 202 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| 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 |