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FDA 510(k)

ACTA VESSEL OCCLUSION SYSTEM (VOS)

K-Number: K091952 · 2010-09-10

ApplicantNfocus Neuromedical, Inc.
Decision Date2010-09-10
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACTA VESSEL OCCLUSION SYSTEM (VOS) is the device name listed in this FDA 510(k) record. The listed applicant is Nfocus Neuromedical, Inc.. It received FDA 510(k) clearance on 2010-09-10 under 510(k) number K091952. 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 ACTA VESSEL OCCLUSION SYSTEM (VOS)?

ACTA VESSEL OCCLUSION SYSTEM (VOS) is a medical device that received FDA 510(k) clearance on 2010-09-10. The listed applicant is Nfocus Neuromedical, Inc.. The 510(k) number is K091952.

When did ACTA VESSEL OCCLUSION SYSTEM (VOS) receive FDA 510(k) clearance?

ACTA VESSEL OCCLUSION SYSTEM (VOS) received FDA 510(k) clearance on 2010-09-10, under 510(k) number K091952.

Who is the listed applicant for ACTA VESSEL OCCLUSION SYSTEM (VOS)?

The FDA 510(k) record lists Nfocus Neuromedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACTA VESSEL OCCLUSION SYSTEM (VOS)?

The FDA product code for ACTA VESSEL OCCLUSION SYSTEM (VOS) is KRD.

Related Clinical Trials

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.

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Other records listing Nfocus Neuromedical, Inc. 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.

K090918NFOCUS NEUROMEDICAL ECHO DISTAL ACCESS CATHETER

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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