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FDA 510(k)

Solitaire 2 and Solitaire Platinum Revascularization Device

K-Number: K181060 · 2018-08-24

ApplicantMedtronic Neurovascular
Decision Date2018-08-24
Product CodePOL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Solitaire 2 and Solitaire Platinum Revascularization Device is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Neurovascular. It received FDA 510(k) clearance on 2018-08-24 under 510(k) number K181060. 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 and Solitaire Platinum Revascularization Device?

Solitaire 2 and Solitaire Platinum Revascularization Device is a medical device that received FDA 510(k) clearance on 2018-08-24. The listed applicant is Medtronic Neurovascular. The 510(k) number is K181060.

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

Solitaire 2 and Solitaire Platinum Revascularization Device received FDA 510(k) clearance on 2018-08-24, under 510(k) number K181060.

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

The FDA 510(k) record lists Medtronic Neurovascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Solitaire 2 and Solitaire Platinum Revascularization Device?

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

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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