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FDA 510(k)

Solitaire Platinum Revascularization Device, 6x40 mm

K-Number: K160641 · 2017-03-08

ApplicantMicro Therapeutics, Inc. d/b/a ev3 Neurovascular
Decision Date2017-03-08
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Solitaire Platinum Revascularization Device, 6x40 mm 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 2017-03-08 under 510(k) number K160641. 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, 6x40 mm?

Solitaire Platinum Revascularization Device, 6x40 mm is a medical device that received FDA 510(k) clearance on 2017-03-08. The listed applicant is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The 510(k) number is K160641.

When did Solitaire Platinum Revascularization Device, 6x40 mm receive FDA 510(k) clearance?

Solitaire Platinum Revascularization Device, 6x40 mm received FDA 510(k) clearance on 2017-03-08, under 510(k) number K160641.

Who is the listed applicant for Solitaire Platinum Revascularization Device, 6x40 mm?

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, 6x40 mm?

The FDA product code for Solitaire Platinum Revascularization Device, 6x40 mm is NRY.

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Related Devices (Code: NRY)

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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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