K210808 is an FDA 510(k) clearance for the Instylla Microcatheter 1.2. This device is classified as a Catheter, Continuous Flush (Class II - Special Controls, product code KRA).
Submitted by Instylla, Inc. (Bedford, US). The FDA issued a Cleared decision on April 15, 2021, 29 days after receiving the submission on March 17, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1210.
| 510(k) Number | K210808 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 17, 2021 |
| Decision Date | April 15, 2021 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | KRA - Catheter, Continuous Flush |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1210 |