The following data is part of a premarket notification filed by Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular with the FDA for Marathon Flow Directed Micro Catheter.
| Device ID | K202318 |
| 510k Number | K202318 |
| Device Name: | Marathon Flow Directed Micro Catheter |
| Classification | Catheter, Continuous Flush |
| Applicant | Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular 9775 Toledo Way Irvine, CA 92618 |
| Contact | Elizabeth Campion |
| Correspondent | Elizabeth Campion Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular 9775 Toledo Way Irvine, CA 92618 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-17 |
| Decision Date | 2020-09-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000400439 | K202318 | 000 |