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FDA 510(k)

OBSIDIO™ Conformable Embolic (M0013972101010)

K-Number: K253376 · 2025-10-30

ApplicantBoston Scientific Corporation
Decision Date2025-10-30
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OBSIDIO™ Conformable Embolic (M0013972101010) is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2025-10-30 under 510(k) number K253376. 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 (M0013972101010)?

OBSIDIO™ Conformable Embolic (M0013972101010) is a medical device that received FDA 510(k) clearance on 2025-10-30. The listed applicant is Boston Scientific Corporation. The 510(k) number is K253376.

When did OBSIDIO™ Conformable Embolic (M0013972101010) receive FDA 510(k) clearance?

OBSIDIO™ Conformable Embolic (M0013972101010) received FDA 510(k) clearance on 2025-10-30, under 510(k) number K253376.

Who is the listed applicant for OBSIDIO™ Conformable Embolic (M0013972101010)?

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

What is the FDA product code for OBSIDIO™ Conformable Embolic (M0013972101010)?

The FDA product code for OBSIDIO™ Conformable Embolic (M0013972101010) is KRD.

Related Clinical Trials

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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 Corporation 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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