The following data is part of a premarket notification filed by Instylla, Inc. with the FDA for Instylla Microcatheter 1.2.
| Device ID | K210808 |
| 510k Number | K210808 |
| Device Name: | Instylla Microcatheter 1.2 |
| Classification | Catheter, Continuous Flush |
| Applicant | Instylla, Inc. 201 Burlington Road, North Building Bedford, MA 01730 |
| Contact | Jennifer Greer |
| Correspondent | Jennifer Greer Instylla, Inc. 201 Burlington Road, North Building Bedford, MA 01730 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-17 |
| Decision Date | 2021-04-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812013030109 | K210808 | 000 |
| 00812013030093 | K210808 | 000 |
| 00812013030086 | K210808 | 000 |