K240486 is an FDA 510(k) clearance for the PM2 System and ECGuide Connector. 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 September 8, 2024, 201 days after receiving the submission on February 20, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K240486 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 20, 2024 |
| Decision Date | September 08, 2024 |
| Days to Decision | 201 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 |