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FDA 510(k)

Riptide Aspiration System

K-Number: K201689 · 2020-07-21

ApplicantMicro Therapeutics, Inc. d/b/a ev3 Neurovascular
Decision Date2020-07-21
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Riptide Aspiration System 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 2020-07-21 under 510(k) number K201689. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Riptide Aspiration System?

Riptide Aspiration System is a medical device that received FDA 510(k) clearance on 2020-07-21. The listed applicant is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The 510(k) number is K201689.

When did Riptide Aspiration System receive FDA 510(k) clearance?

Riptide Aspiration System received FDA 510(k) clearance on 2020-07-21, under 510(k) number K201689.

Who is the listed applicant for Riptide Aspiration System?

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 Riptide Aspiration System?

The FDA product code for Riptide Aspiration System is NRY.

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 SystemK211990Rist 071 Radial Access Guide CatheterK203432Axium Detachable Coil; Axium Prime Detachable Coil

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Related Devices (Code: NRY)

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.

K262398CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setCERENOVUS, Inc.K262399Millipede SystemPerfuze, Ltd.K262391APRO 35 Swift Catheter and Alembic Aspiration TubingAlembic, LLCK260002Socrates Aspiration System (Socrates 70 Aspiration Catheter)Scientia Vascular, Inc.K250690Penumbra System (Thunderbolt Aspiration Tubing)Penumbra, Inc.K252707Zenith Aspiration Catheter; Disposable Aspiration Tubing SetSuzhou Zenith Vascular SciTech Limited

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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