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FDA 510(k)

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

K-Number: K090932 · 2009-09-24

ApplicantNexgen Medical Systems, Inc.
Decision Date2009-09-24
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000; 80 CM, MODEL MRD-2000 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 2009-09-24 under 510(k) number K090932. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000; 80 CM, MODEL MRD-2000?

NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000; 80 CM, MODEL MRD-2000 is a medical device that received FDA 510(k) clearance on 2009-09-24. The listed applicant is Nexgen Medical Systems, Inc.. The 510(k) number is K090932.

When did NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000; 80 CM, MODEL MRD-2000 receive FDA 510(k) clearance?

NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000; 80 CM, MODEL MRD-2000 received FDA 510(k) clearance on 2009-09-24, under 510(k) number K090932.

Who is the listed applicant for NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000; 80 CM, MODEL MRD-2000?

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 - 200CM, MODEL MRD-1000; 80 CM, MODEL MRD-2000?

The FDA product code for NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000; 80 CM, MODEL MRD-2000 is QEW.

Related Clinical Trials

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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 CATHETERK110315NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICEK102979NEXGEN PERIPHERAL GUIDE CATHETER

Related Devices (Code: QEW)

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.

K253419Triever Duo CatheterInari Medical, Inc.K261800Helo Max Thrombectomy System (HEL2090)Endovascular EngineeringK262538Artix™ MT;Artix™ Thin-Walled SheathInari Medical, Inc.K261523Vertex™ Thrombectomy SystemJupiter EndovascularK260599INDIGO® Aspiration System – INDIGO LinkPenumbra, Inc.K260028CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration CanisterArgon Medical Devices, 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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