The following data is part of a premarket notification filed by Micro Therapeutics Inc Dba Ev3 Neurovascular with the FDA for Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter.
| Device ID | K150107 |
| 510k Number | K150107 |
| Device Name: | Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | MICRO THERAPEUTICS INC DBA EV3 NEUROVASCULAR 9775 TOLEDO WAY Irvine, CA 92618 |
| Contact | Phuong Chau |
| Correspondent | Phuong Chau MICRO THERAPEUTICS INC DBA EV3 NEUROVASCULAR 9775 TOLEDO WAY Irvine, CA 92618 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-20 |
| Decision Date | 2015-07-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847536024625 | K150107 | 000 |
| 00847536024618 | K150107 | 000 |
| 00847536003927 | K150107 | 000 |
| 00847536003460 | K150107 | 000 |