Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device)

K-Number: K181807 · 2019-03-06

ApplicantMicro Therapeutics, Inc. d/b/a ev3 Neurovascular
Decision Date2019-03-06
Product CodePOL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Solitaire 2 Revascularization Device, Solitaire Platinum 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 2019-03-06 under 510(k) number K181807. 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 Platinum Revascularization Device (Solitaire Revascularization Device)?

Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device) is a medical device that received FDA 510(k) clearance on 2019-03-06. The listed applicant is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The 510(k) number is K181807.

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

Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device) received FDA 510(k) clearance on 2019-03-06, under 510(k) number K181807.

Who is the listed applicant for Solitaire 2 Revascularization Device, Solitaire Platinum 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 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device)?

The FDA product code for Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device) is POL.

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

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.

PMA P100018Intracranial aneurysm flow diverterK241388Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective CatheterK243418Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate TubingK243080Riptide Aspiration SystemK211990Rist 071 Radial Access Guide CatheterK203432Axium Detachable Coil; Axium Prime Detachable Coil

View all 28 devices →

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.

↑