The following data is part of a premarket notification filed by Piccolo Medical, Inc with the FDA for Piccolo Medical Smartpicc System.
| Device ID | K200037 |
| 510k Number | K200037 |
| Device Name: | Piccolo Medical SmartPICC System |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | Piccolo Medical, Inc 101 Mississippi St San Fransico, CA 94107 |
| Contact | Alexey Salamini |
| Correspondent | Allison Kumar Arina Consulting 27 Hilltop Drive San Carlos, CA 94070 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-08 |
| Decision Date | 2021-01-22 |