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FDA 510(k)

Solitaire Platinum Revascularization Device

K-Number: K161879 · 2016-09-21

ApplicantMicro Therapeutics, Inc. d/b/a ev3 Neurovascular
Decision Date2016-09-21
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Solitaire Platinum Revascularization Device 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 2016-09-21 under 510(k) number K161879. 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 Solitaire Platinum Revascularization Device?

Solitaire Platinum Revascularization Device is a medical device that received FDA 510(k) clearance on 2016-09-21. The listed applicant is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The 510(k) number is K161879.

When did Solitaire Platinum Revascularization Device receive FDA 510(k) clearance?

Solitaire Platinum Revascularization Device received FDA 510(k) clearance on 2016-09-21, under 510(k) number K161879.

Who is the listed applicant for Solitaire Platinum Revascularization Device?

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 Solitaire Platinum Revascularization Device?

The FDA product code for Solitaire Platinum Revascularization Device is NRY.

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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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