Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Embolic Acceleration, LLC. It received FDA 510(k) clearance on 2020-02-14 under 510(k) 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. The listed applicant is Embolic Acceleration, LLC. The 510(k) number is K200083.

When did EMBA Hourglass Peripheral Embolization Device (PED) receive FDA 510(k) clearance?

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

Who is the listed applicant for EMBA Hourglass Peripheral Embolization Device (PED)?

The FDA 510(k) record lists Embolic Acceleration, LLC as the applicant. This does not by itself establish the device manufacturer.

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 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.

↑