Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter (K241388)
Description
Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241388
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter (K241388) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211990 | Rist 071 Radial Access Guide Catheter | Micro Therapeutics, Inc. d/b/a ev3 ... | 2021 |
| K201682 | RIST Radial Access Catheter | Rist Neurovascular, Inc. | 2020 |
| K191551 | RIST Cath Radial Access Long Sheath | Rist Neurovascular, Inc. | 2019 |
Trace the full predicate network for K241388
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.