FDA 510(k)

OBSIDIO Conformable Embolic

K-Number: K242507 · 2024-10-03

Decision Date2024-10-03

Product CodeKRD

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

OBSIDIO Conformable Embolic is a medical device manufactured by Boston Scientific. It received FDA 510(k) clearance on 2024-10-03 under approval 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. It is manufactured by Boston Scientific. The 510(k) number is K242507.

When was OBSIDIO Conformable Embolic approved by the FDA?

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

What company makes OBSIDIO Conformable Embolic?

OBSIDIO Conformable Embolic is manufactured by Boston Scientific.

What is the FDA product code for OBSIDIO Conformable Embolic?

The FDA product code for OBSIDIO Conformable Embolic is KRD.

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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.