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 System.
| Device ID | K133310 |
| 510k Number | K133310 |
| Device Name: | AXIUM DETACHABLE COIL SYSTEM |
| Classification | Device, Neurovascular Embolization |
| Applicant | MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR 9775 TOLEDO WAY Irvine, CA 92618 |
| Contact | Angela Lamprey |
| Correspondent | Angela Lamprey MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR 9775 TOLEDO WAY Irvine, CA 92618 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-28 |
| Decision Date | 2014-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847536017153 | K133310 | 000 |
| 00836462010017 | K133310 | 000 |
| 00847536029408 | K133310 | 000 |
| 00847536001879 | K133310 | 000 |
| 00847536001886 | K133310 | 000 |
| 00847536001893 | K133310 | 000 |
| 00847536001909 | K133310 | 000 |
| 00847536001916 | K133310 | 000 |
| 00847536001923 | K133310 | 000 |
| 00847536001930 | K133310 | 000 |
| 00847536001947 | K133310 | 000 |
| 00847536001954 | K133310 | 000 |
| 00847536001961 | K133310 | 000 |
| 00847536001978 | K133310 | 000 |
| 00847536001985 | K133310 | 000 |
| 00847536001992 | K133310 | 000 |
| 00847536002005 | K133310 | 000 |
| 00847536002012 | K133310 | 000 |
| 00847536037212 | K133310 | 000 |