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FDA 510(k)

OBSIDIO™ Conformable Embolic

K-Number: K242507 · 2024-10-03

ApplicantBoston Scientific
Decision Date2024-10-03
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OBSIDIO™ Conformable Embolic is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2024-10-03 under 510(k) number K242507. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OBSIDIO™ Conformable Embolic?

OBSIDIO™ Conformable Embolic is a medical device that received FDA 510(k) clearance on 2024-10-03. The listed applicant is Boston Scientific. The 510(k) number is K242507.

When did OBSIDIO™ Conformable Embolic receive FDA 510(k) clearance?

OBSIDIO™ Conformable Embolic received FDA 510(k) clearance on 2024-10-03, under 510(k) number K242507.

Who is the listed applicant for OBSIDIO™ Conformable Embolic?

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

What is the FDA product code for OBSIDIO™ Conformable Embolic?

The FDA product code for OBSIDIO™ Conformable Embolic is KRD.

Related Clinical Trials

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.

NCT06170619Obsidio™ Conformable Embolic RegistryCOMPLETEDNCT01385176Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)ACTIVE_NOT_RECRUITINGNCT01550575Patient Retrospective Outcomes (PRO)RECRUITINGNCT01719055RELIEF - A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for PainRECRUITINGNCT02071134Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS RegistryRECRUITINGNCT02686125Vercise™ DBS Dystonia Prospective StudyRECRUITING

Other records listing Boston Scientific 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.

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Related Devices (Code: KRD)

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.

K252812UniPearls® Embolic MicrospheresSuzhou Haowei Medical Technology Co., Ltd.K261488OBSIDIO Conformable EmbolicBoston Scientific CorporationK261866Concerto Versa™ Detachable CoilMedtronic, Inc.K260635HARBOR Occlusion DeviceNuvascular, Inc.K260508LOBO Vascular Occlusion SystemOkami Medical, Inc.K253511Concerto Versa™ Detachable CoilMedtronic, Inc.

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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