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FDA 510(k)

EMBA Hourglass Peripheral Embolization Device (PED)

K-Number: K200083 · 2020-02-14

ApplicantEmbolic Acceleration, LLC
Decision Date2020-02-14
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EMBA Hourglass Peripheral Embolization Device (PED) is a medical device manufactured by Embolic Acceleration, LLC. It received FDA 510(k) clearance on 2020-02-14 under approval number K200083. 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 EMBA Hourglass Peripheral Embolization Device (PED)?

EMBA Hourglass Peripheral Embolization Device (PED) is a medical device that received FDA 510(k) clearance on 2020-02-14. It is manufactured by Embolic Acceleration, LLC. The 510(k) number is K200083.

When was EMBA Hourglass Peripheral Embolization Device (PED) approved by the FDA?

EMBA Hourglass Peripheral Embolization Device (PED) received FDA 510(k) clearance on 2020-02-14, under approval number K200083.

What company makes EMBA Hourglass Peripheral Embolization Device (PED)?

EMBA Hourglass Peripheral Embolization Device (PED) is manufactured by Embolic Acceleration, LLC.

What is the FDA product code for EMBA Hourglass Peripheral Embolization Device (PED)?

The FDA product code for EMBA Hourglass Peripheral Embolization Device (PED) is KRD.

Related Clinical Trials

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Related PubMed Literature

PMID: 41112966 Vascular Reconstruction Device for Coil Embolization of Wide-Neck Type Cerebral Aneurysm: Findings from a Post-Marketing Surveillance Study in Japan. Journal of neuroendovascular therapy (2025)

Related Devices (Code: KRD)

K162373LC Bead LUMIBiocompatibles UK Limited K160219Hilal Embolization MicroCoilsCook Incorporated K153778Nester Embolization Coils, Tornado Embolization CoilsCook Incorporated K150876Bead BlockBiocompatibles UK , Ltd. K171946Gel-BeadVascular Solutions, Inc. K172372QuadraSphere MicrospheresBiosphere Medical, S.A.

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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