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 |