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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 the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2022-04-12 under 510(k) 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. The listed applicant is Boston Scientific Corporation. The 510(k) number is K213398.

When did EMBOLD Fibered Detachable Coil System receive FDA 510(k) clearance?

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

Who is the listed applicant for EMBOLD Fibered Detachable Coil System?

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 EMBOLD Fibered Detachable Coil System?

The FDA product code for EMBOLD Fibered Detachable Coil System 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.

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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