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FDA 510(k)

BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER

K-Number: K043371 · 2005-02-03

ApplicantBiomerix Corporation
Decision Date2005-02-03
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER is the device name listed in this FDA 510(k) record. The listed applicant is Biomerix Corporation. It received FDA 510(k) clearance on 2005-02-03 under 510(k) number K043371. 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 BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER?

BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER is a medical device that received FDA 510(k) clearance on 2005-02-03. The listed applicant is Biomerix Corporation. The 510(k) number is K043371.

When did BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER receive FDA 510(k) clearance?

BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER received FDA 510(k) clearance on 2005-02-03, under 510(k) number K043371.

Who is the listed applicant for BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER?

The FDA 510(k) record lists Biomerix Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER?

The FDA product code for BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER is KRD.

Related Clinical Trials

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Other records listing Biomerix Corporation as applicant

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.

K112567BIOMERIX ASSUREK112499BIOMERIX COMPOSITE SURGICAL MESHK093123BIOMERIX VENTRAL HERNIA REPAIR MESH, MODEL SM3-TABK082941BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215K070961BIOMERIX SURGICAL MESH, MODEL: RCR-01

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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