RIST Radial Access Catheter
by Rist Neurovascular, Inc. 2 variants
510(k) K201682
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK201682 | Date28 Sep 2020 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- QJP
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1250
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Rist Radial Access Catheter is a percutaneous neurovascular catheter designed for radial artery access in neurointerventional procedures. It facilitates the delivery of neurovascular devices to target vessels via the radial pathway, offering specialized transition zones and optimized lumen diameter for precise navigation.
This catheter is supplied as a single-use, non-sterile device (unless sterilized by the manufacturer) and is intended for use in controlled clinical settings such as catheterization labs. It is classified as a Class II medical device under FDA regulations (21 CFR 870.1250) and holds a 510(k) clearance for substantial equivalence. Multiple reference codes (e.g., 3012543881, 1047843) correspond to its regulatory submissions, ensuring compliance with neurovascular procedural standards.
Other devices from Rist Neurovascular, Inc.
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the RIST Radial Access Catheter in neurointerventional procedures?
The RIST Radial Access Catheter is specifically designed for radial artery access during neurointerventional procedures. It facilitates the delivery of neurovascular devices to target vessels through the radial pathway, featuring specialized transition zones and an optimized lumen diameter to ensure precise navigation and effective device deployment.
Is the RIST Radial Access Catheter intended for single-use or can it be reused?
The RIST Radial Access Catheter is supplied as a single-use device, though it may be sterilized by the manufacturer. This design ensures patient safety and reduces the risk of contamination or cross-infection, which is critical in controlled clinical settings like catheterization labs.
What regulatory pathway was followed for the FDA clearance of the RIST Radial Access Catheter?
The RIST Radial Access Catheter received FDA clearance through a 510(k) submission, which demonstrates substantial equivalence to a predicate device. The clearance was granted under the traditional review pathway by the Cardiovascular (CV) Advisory Committee, with a decision date of September 28, 2020, and a 510(k) number of K201682.
How should the RIST Radial Access Catheter be stored, and is it sterile upon receipt?
The RIST Radial Access Catheter is supplied as a non-sterile device unless sterilized by the manufacturer. Storage instructions are not explicitly detailed in the provided data, but it should be stored in a clean, dry environment as per standard medical device handling protocols to maintain its integrity until use in a controlled clinical setting.
What types of neurovascular devices can be delivered using the RIST Radial Access Catheter?
While the exact types of neurovascular devices compatible with the RIST Radial Access Catheter are not specified in the provided data, its design—including specialized transition zones and optimized lumen diameter—suggests it is intended for delivering a range of neurointerventional tools, such as microcatheters, guidewires, and embolic agents, through the radial artery pathway to target cerebral vessels.