The following data is part of a premarket notification filed by Balt Usa, Llc with the FDA for Magic Infusion Catheter.
| Device ID | K202366 |
| 510k Number | K202366 |
| Device Name: | MAGIC Infusion Catheter |
| Classification | Catheter, Continuous Flush |
| Applicant | Balt USA, LLC 29 Parker Irvine, CA 92618 |
| Contact | Corina Pierson |
| Correspondent | Corina Pierson Balt USA, LLC 29 Parker Irvine, CA 92618 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-19 |
| Decision Date | 2021-01-29 |