The following data is part of a premarket notification filed by Agile Devices, Inc. with the FDA for Agile Devices Angler Steerable, Deflectable Microcatheter.
| Device ID | K211110 |
| 510k Number | K211110 |
| Device Name: | Agile Devices Angler Steerable, Deflectable Microcatheter |
| Classification | Catheter, Continuous Flush |
| Applicant | Agile Devices, Inc. 69 Fox Hill Road Wellesley, MA 02481 |
| Contact | Stephen Tully |
| Correspondent | Stephen Tully Strategic Device Solutions LLC 20 Lawton Lane Foxborough, MA 02035 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-14 |
| Decision Date | 2022-01-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G544AMD147 | K211110 | 000 |
| G544ADM130 | K211110 | 000 |