The following data is part of a premarket notification filed by Rist Neurovascular, Inc. with the FDA for Rist Cath Radial Access Long Sheath.
| Device ID | K191551 |
| 510k Number | K191551 |
| Device Name: | RIST Cath Radial Access Long Sheath |
| Classification | Catheter, Percutaneous |
| Applicant | RIST Neurovascular, Inc. 11611 Interchange Circle S Miramar, FL 33025 |
| Contact | Marianne Grumwaldt |
| Correspondent | Elena Jugo Caraballo Consulting 11037 Bitternut Hickory Lane Boynton Beach, FL 33437 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-12 |
| Decision Date | 2019-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000413781 | K191551 | 000 |
| 00763000413774 | K191551 | 000 |
| 00763000413767 | K191551 | 000 |