The following data is part of a premarket notification filed by Smartwise Sweden Ab with the FDA for Extroducer Infusion Catheter System.
| Device ID | K213442 |
| 510k Number | K213442 |
| Device Name: | Extroducer Infusion Catheter System |
| Classification | Catheter, Continuous Flush |
| Applicant | Smartwise Sweden AB Alfred Nobels Allé 150 Tullinge, SE SE-146 48 |
| Contact | Maria Nordlinder |
| Correspondent | Maria Nordlinder Smartwise Sweden AB Alfred Nobels Allé 150 Tullinge, SE SE-146 48 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-25 |
| Decision Date | 2022-06-10 |