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FDA 510(k)

Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device)

K-Number: K193576 · 2020-11-20

ApplicantMicro Therapeutics, Inc. d/b/a ev3 Neurovascular
Decision Date2020-11-20
Product CodePOL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire 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 2020-11-20 under 510(k) number K193576. The device is classified under product code POL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device)?

Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device) is a medical device that received FDA 510(k) clearance on 2020-11-20. The listed applicant is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The 510(k) number is K193576.

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

Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device) received FDA 510(k) clearance on 2020-11-20, under 510(k) number K193576.

Who is the listed applicant for Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire 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, Solitaire X Revascularization Device (Solitaire Revascularization Device)?

The FDA product code for Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device) is POL.

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Related Devices (Code: POL)

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.

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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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