The following data is part of a premarket notification filed by Rist Neurovascular, Inc. with the FDA for Rist Radial Access Catheter.
| Device ID | K200417 |
| 510k Number | K200417 |
| Device Name: | RIST Radial Access Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | RIST Neurovascular, Inc. 11611 Interchange Circle South Miramar, FL 33025 |
| Contact | Marianne Grumwaldt |
| Correspondent | Vyoma Upadhya Chikara RIST Neurovascular, Inc. 11611 Interchange Circle South Miramar, FL 33025 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-20 |
| Decision Date | 2020-05-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000413828 | K200417 | 000 |
| 00763000413811 | K200417 | 000 |
| 00763000413804 | K200417 | 000 |
| 00763000413798 | K200417 | 000 |