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FDA 510(k)

EMBOLD™ Soft Detachable Coil System

K-Number: K230706 · 2023-06-27

ApplicantBoston Scientific Corporation
Decision Date2023-06-27
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EMBOLD™ Soft Detachable Coil System is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2023-06-27 under approval number K230706. 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 EMBOLD™ Soft Detachable Coil System?

EMBOLD™ Soft Detachable Coil System is a medical device that received FDA 510(k) clearance on 2023-06-27. It is manufactured by Boston Scientific Corporation. The 510(k) number is K230706.

When was EMBOLD™ Soft Detachable Coil System approved by the FDA?

EMBOLD™ Soft Detachable Coil System received FDA 510(k) clearance on 2023-06-27, under approval number K230706.

What company makes EMBOLD™ Soft Detachable Coil System?

EMBOLD™ Soft Detachable Coil System is manufactured by Boston Scientific Corporation.

What is the FDA product code for EMBOLD™ Soft Detachable Coil System?

The FDA product code for EMBOLD™ Soft Detachable Coil System 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.

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