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FDA 510(k)

F.A.S.T. SYSTEM SED AND CXD

K-Number: K092623 · 2009-10-30

ApplicantGenesis Medical Interventional, Inc.
Decision Date2009-10-30
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

F.A.S.T. SYSTEM SED AND CXD is the device name listed in this FDA 510(k) record. The listed applicant is Genesis Medical Interventional, Inc.. It received FDA 510(k) clearance on 2009-10-30 under 510(k) number K092623. 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 F.A.S.T. SYSTEM SED AND CXD?

F.A.S.T. SYSTEM SED AND CXD is a medical device that received FDA 510(k) clearance on 2009-10-30. The listed applicant is Genesis Medical Interventional, Inc.. The 510(k) number is K092623.

When did F.A.S.T. SYSTEM SED AND CXD receive FDA 510(k) clearance?

F.A.S.T. SYSTEM SED AND CXD received FDA 510(k) clearance on 2009-10-30, under 510(k) number K092623.

Who is the listed applicant for F.A.S.T. SYSTEM SED AND CXD?

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

What is the FDA product code for F.A.S.T. SYSTEM SED AND CXD?

The FDA product code for F.A.S.T. SYSTEM SED AND CXD is QEW.

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 Genesis Medical Interventional, 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.

K040010GENESIS MEDICAL INTERVENTIONAL F.A.S.T. (FACILITATED ASPIRATION/SUCTION THROMBECTOMY) SYSTEMS

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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