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

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 a medical device manufactured by Medtronic Neurovascular. It received FDA 510(k) clearance on 2018-08-24 under approval 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. It is manufactured by Medtronic Neurovascular. The 510(k) number is K181060.

When was Solitaire 2 and Solitaire Platinum Revascularization Device approved by the FDA?

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

What company makes Solitaire 2 and Solitaire Platinum Revascularization Device?

Solitaire 2 and Solitaire Platinum Revascularization Device is manufactured by Medtronic Neurovascular.

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 Clinical Trials

NCT07226193 Detecting Peripheral Artery Disease With the Pulse RECRUITING NCT05650411 Ultrathin-strut Biodegradable Polymer Sirolimus-eluting Stents With P2Y12 Inhibitor-based Single Antiplatelet Therapy vs. Conventional DAPT for Unprotected Left Main Coronary Artery Disease (ULTIMATE-LM) RECRUITING NCT00698607 Efficacy of Xience/Promus Versus Cypher in rEducing Late Loss After stENTing COMPLETED NCT03601702 EmboTrap ® II Revascularization Device (Neuravi) in Acute Ischemic Stroke RECRUITING NCT06733246 Safety and Efficacy Evaluation of the Ceretrieve Device in the Treatment of AIS Patients RECRUITING

Related Devices (Code: POL)

K162539Solitaire 2 Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular DEN150049Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mmConcentric Medical, Inc. K181186Solitare Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular K173352Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)Concentric Medical, Inc. K192207Trevo NXT ProVue RetrieverStryker K190779Trevo XP ProVue RetrieverStryker

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.

↑