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FDA 510(k)

RIST Cath Radial Access Long Sheath

K-Number: K191551 · 2019-12-23

ApplicantRist Neurovascular, Inc.
Decision Date2019-12-23
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RIST Cath Radial Access Long Sheath is a medical device manufactured by Rist Neurovascular, Inc.. It received FDA 510(k) clearance on 2019-12-23 under approval number K191551. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RIST Cath Radial Access Long Sheath?

RIST Cath Radial Access Long Sheath is a medical device that received FDA 510(k) clearance on 2019-12-23. It is manufactured by Rist Neurovascular, Inc.. The 510(k) number is K191551.

When was RIST Cath Radial Access Long Sheath approved by the FDA?

RIST Cath Radial Access Long Sheath received FDA 510(k) clearance on 2019-12-23, under approval number K191551.

What company makes RIST Cath Radial Access Long Sheath?

RIST Cath Radial Access Long Sheath is manufactured by Rist Neurovascular, Inc..

What is the FDA product code for RIST Cath Radial Access Long Sheath?

The FDA product code for RIST Cath Radial Access Long Sheath is DQY.

Related Clinical Trials

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Other Devices by Rist Neurovascular, Inc.

K201682RIST Radial Access Catheter K200417RIST Radial Access Catheter

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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