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FDA 510(k)

Solitaire 2 Revascularization Device

K-Number: K162539 · 2016-11-10

ApplicantMicro Therapeutics, Inc. d/b/a ev3 Neurovascular
Decision Date2016-11-10
Product CodePOL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Solitaire 2 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 2016-11-10 under 510(k) number K162539. 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 2 Revascularization Device?

Solitaire 2 Revascularization Device is a medical device that received FDA 510(k) clearance on 2016-11-10. The listed applicant is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The 510(k) number is K162539.

When did Solitaire 2 Revascularization Device receive FDA 510(k) clearance?

Solitaire 2 Revascularization Device received FDA 510(k) clearance on 2016-11-10, under 510(k) number K162539.

Who is the listed applicant for Solitaire 2 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 2 Revascularization Device?

The FDA product code for Solitaire 2 Revascularization Device is POL.

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

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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.

K242676pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy DevicePhenox LimitedK231539pRESET LITE Thrombectomy DevicePhenox LimitedK223305Trevo NXT ProVue RetrieverStryker NeurovascularK222848pRESET Thrombectomy DevicePhenox LimitedK210502Trevo NXT ProVue RetrieverStryker NeurovascularK203358Solitaire X Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular

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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