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 |