The following data is part of a premarket notification filed by Micro Therapeutics, Inc., D/b/a Ev3 Neurovascular with the FDA for Rist 071 Radial Access Guide Catheter.
| Device ID | K211990 |
| 510k Number | K211990 |
| Device Name: | Rist 071 Radial Access Guide Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | Micro Therapeutics, Inc., D/b/a Ev3 Neurovascular 9775 Toledo Way Irvine, CA 92618 |
| Contact | Amnon Talmor |
| Correspondent | Marianne Grunwaldt InNeuroCo, Inc. 19700 Sterling Road, Suite 1 Pembroke Pines, FL 33332 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-28 |
| Decision Date | 2021-07-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000541217 | K211990 | 000 |
| 00763000541200 | K211990 | 000 |
| 00763000541194 | K211990 | 000 |