Skip to content

RIST Cath Radial Access Long Sheath

by Rist Neurovascular, Inc.

510(k) K191551

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK191551 Date23 Dec 2019ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DQY
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The RIST Cath Radial Access Long Sheath is a specialized catheter designed to facilitate access to the neurovascular system via the radial artery. It provides a long, flexible conduit that allows for the passage of diagnostic and therapeutic tools to the target site within the cerebral vasculature.

This device is supplied by Rist Neurovascular, Inc. and was cleared through the FDA 510(k) process under k-number K191551 with product code DQY. It is intended for use in neurovascular procedures requiring precise navigation and stability via radial artery access.

Other devices from Rist Neurovascular, Inc.