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FDA 510(k)

NEXGEN PERIPHERAL GUIDE CATHETER

K-Number: K102979 · 2011-01-18

ApplicantNexgen Medical Systems, Inc.
Decision Date2011-01-18
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NEXGEN PERIPHERAL GUIDE CATHETER 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 2011-01-18 under 510(k) number K102979. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEXGEN PERIPHERAL GUIDE CATHETER?

NEXGEN PERIPHERAL GUIDE CATHETER is a medical device that received FDA 510(k) clearance on 2011-01-18. The listed applicant is Nexgen Medical Systems, Inc.. The 510(k) number is K102979.

When did NEXGEN PERIPHERAL GUIDE CATHETER receive FDA 510(k) clearance?

NEXGEN PERIPHERAL GUIDE CATHETER received FDA 510(k) clearance on 2011-01-18, under 510(k) number K102979.

Who is the listed applicant for NEXGEN PERIPHERAL GUIDE CATHETER?

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 GUIDE CATHETER?

The FDA product code for NEXGEN PERIPHERAL GUIDE CATHETER is DQY.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 CATHETERK110315NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICEK090932NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000; 80 CM, MODEL MRD-2000

Related Devices (Code: DQY)

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.

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott

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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