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FDA 510(k)

Rist 071 Radial Access Guide Catheter

K-Number: K211990 · 2021-07-27

ApplicantMicro Therapeutics, Inc. d/b/a ev3 Neurovascular
Decision Date2021-07-27
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Rist 071 Radial Access Guide Catheter is a medical device manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. It received FDA 510(k) clearance on 2021-07-27 under approval number K211990. 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 071 Radial Access Guide Catheter?

Rist 071 Radial Access Guide Catheter is a medical device that received FDA 510(k) clearance on 2021-07-27. It is manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The 510(k) number is K211990.

When was Rist 071 Radial Access Guide Catheter approved by the FDA?

Rist 071 Radial Access Guide Catheter received FDA 510(k) clearance on 2021-07-27, under approval number K211990.

What company makes Rist 071 Radial Access Guide Catheter?

Rist 071 Radial Access Guide Catheter is manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular.

What is the FDA product code for Rist 071 Radial Access Guide Catheter?

The FDA product code for Rist 071 Radial Access Guide Catheter is DQY.

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Related Devices (Code: DQY)

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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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