The following data is part of a premarket notification filed by Instylla, Inc. with the FDA for Instylla Microcatheter.
| Device ID | K191731 |
| 510k Number | K191731 |
| Device Name: | Instylla Microcatheter |
| Classification | Catheter, Continuous Flush |
| Applicant | Instylla, Inc. 204 Second Avenue Waltham, MA 02451 |
| Contact | Amita Shah |
| Correspondent | Amita Shah Instylla, Inc. 204 Second Avenue Waltham, MA 02451 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-28 |
| Decision Date | 2019-08-13 |