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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 the device name listed in this FDA 510(k) record. The listed applicant is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. It received FDA 510(k) clearance on 2021-07-27 under 510(k) 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. The listed applicant is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The 510(k) number is K211990.

When did Rist 071 Radial Access Guide Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Rist 071 Radial Access Guide Catheter?

The FDA 510(k) record lists Micro Therapeutics, Inc. d/b/a ev3 Neurovascular as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06107361Evaluating the Role of the Guidewire in Peripheral Intravenous Access: A Randomized Controlled Trial of Ultrasound-Guided Catheter SurvivalRECRUITINGNCT06668766Single Lumen Midline Catheter vs Long Peripheral Intravenous Cather for Difficult Intravenous Access in the EDCOMPLETEDNCT07762560Routine Microaxial Heart Pump Support and Protocolized Pulmonary Artery Catheter Monitoring Versus Standard Care in Heart Attack-Related Cardiogenic ShockNOT_YET_RECRUITINGNCT07779317Single Lumen Midline Catheter vs Ultrasound Guided Peripheral IV as Performed by Bedside Emergency Department Registered NursesRECRUITING

Other records listing Micro Therapeutics, Inc. d/b/a ev3 Neurovascular as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P100018Intracranial aneurysm flow diverterK241388Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective CatheterK243418Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate TubingK243080Riptide Aspiration SystemK203432Axium Detachable Coil; Axium Prime Detachable CoilK203358Solitaire X Revascularization Device

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Related Devices (Code: DQY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbottK261631Amplatzer TorqVue Exchange SystemAbbott Medical

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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