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FDA 510(k)

EMBOLD Fibered Detachable Coil System

K-Number: K213398 · 2022-04-12

ApplicantBoston Scientific Corporation
Decision Date2022-04-12
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EMBOLD Fibered Detachable Coil System is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2022-04-12 under approval number K213398. 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 Fibered Detachable Coil System?

EMBOLD Fibered Detachable Coil System is a medical device that received FDA 510(k) clearance on 2022-04-12. It is manufactured by Boston Scientific Corporation. The 510(k) number is K213398.

When was EMBOLD Fibered Detachable Coil System approved by the FDA?

EMBOLD Fibered Detachable Coil System received FDA 510(k) clearance on 2022-04-12, under approval number K213398.

What company makes EMBOLD Fibered Detachable Coil System?

EMBOLD Fibered Detachable Coil System is manufactured by Boston Scientific Corporation.

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

The FDA product code for EMBOLD Fibered 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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