The following data is part of a premarket notification filed by Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular with the FDA for Axium Detachable Coil; Axium Prime Detachable Coil.
Device ID | K203432 |
510k Number | K203432 |
Device Name: | Axium Detachable Coil; Axium Prime Detachable Coil |
Classification | Device, Neurovascular Embolization |
Applicant | Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular 5290 California Ave Irvine, CA 92617 |
Contact | Bhavika Patel |
Correspondent | Bhavika Patel Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular 5290 California Ave Irvine, CA 92617 |
Product Code | HCG |
CFR Regulation Number | 882.5950 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-11-23 |
Decision Date | 2021-07-07 |