K200037 is an FDA 510(k) clearance for the Piccolo Medical SmartPICC System. 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 January 22, 2021, 380 days after receiving the submission on January 8, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K200037 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 08, 2020 |
| Decision Date | January 22, 2021 |
| Days to Decision | 380 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 |