The following data is part of a premarket notification filed by Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular with the FDA for Riptide Aspiration System (riptide Large Bore Aspiration System).
| Device ID | K183185 |
| 510k Number | K183185 |
| Device Name: | Riptide Aspiration System (Riptide Large Bore Aspiration System) |
| Classification | Catheter, Thrombus Retriever |
| Applicant | Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular 9775 Toledo Way Irvine, CA 92618 |
| Contact | Nancy Drew |
| Correspondent | Nancy Drew Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular 9775 Toledo Way Irvine, CA 92618 |
| Product Code | NRY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-19 |
| Decision Date | 2018-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847536034839 | K183185 | 000 |
| 00763000299439 | K183185 | 000 |