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FDA 510(k)

OBSIDIO Conformable Embolic

K-Number: K261488 · 2026-07-24

ApplicantBoston Scientific Corporation
Decision Date2026-07-24
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 Corporation. It received FDA 510(k) clearance on 2026-07-24 under 510(k) number K261488. 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 2026-07-24. The listed applicant is Boston Scientific Corporation. The 510(k) number is K261488.

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

OBSIDIO Conformable Embolic received FDA 510(k) clearance on 2026-07-24, under 510(k) number K261488.

Who is the listed applicant for OBSIDIO Conformable Embolic?

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?

The FDA product code for OBSIDIO Conformable Embolic is KRD.

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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.

K261866Concerto Versa™ Detachable CoilMedtronic, Inc.K260635HARBOR Occlusion DeviceNuvascular, Inc.K260508LOBO Vascular Occlusion SystemOkami Medical, Inc.K253511Concerto Versa™ Detachable CoilMedtronic, Inc.K253677Tembo Embolic SystemInstylla, Inc.K253376OBSIDIO™ Conformable Embolic (M0013972101010)Boston Scientific Corporation

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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