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FDA 510(k)

NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE

K-Number: K110315 · 2011-10-20

ApplicantNexgen Medical Systems, Inc.
Decision Date2011-10-20
Product CodeQEZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Nexgen Medical Systems, Inc.. It received FDA 510(k) clearance on 2011-10-20 under 510(k) number K110315. The device is classified under product code QEZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE?

NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE is a medical device that received FDA 510(k) clearance on 2011-10-20. The listed applicant is Nexgen Medical Systems, Inc.. The 510(k) number is K110315.

When did NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE receive FDA 510(k) clearance?

NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE received FDA 510(k) clearance on 2011-10-20, under 510(k) number K110315.

Who is the listed applicant for NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE?

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

What is the FDA product code for NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE?

The FDA product code for NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE is QEZ.

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 Nexgen Medical Systems, 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.

K102925NEXGEN EXPANDABLE CATHETERK102979NEXGEN PERIPHERAL GUIDE CATHETERK090932NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000; 80 CM, MODEL MRD-2000

Related Devices (Code: QEZ)

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.

K254035Mayumi™ Thrombectomy SystemMicroVention, Inc., d/b/a Terumo NeuroK261105Powered Aventus Thrombectomy System™Inquis MedicalK262030Aventus Thrombectomy SystemInquis MedicalK253589Liberant™ RX Aspiration CatheterMedtronic Interventional Vascular, Inc.K254208FLOWRUNNER Aspiration SystemExpanse Medical, Inc.K253925Aventus Thrombectomy SystemInquis Medical

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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