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FDA 510(k)

D-CLOT THROMBECTOMY CATHETER SYSTEM, MODEL: DC 4006

K-Number: K083370 · 2008-12-12

ApplicantArtegraft, Inc.
Decision Date2008-12-12
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

D-CLOT THROMBECTOMY CATHETER SYSTEM, MODEL: DC 4006 is the device name listed in this FDA 510(k) record. The listed applicant is Artegraft, Inc.. It received FDA 510(k) clearance on 2008-12-12 under 510(k) number K083370. 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 D-CLOT THROMBECTOMY CATHETER SYSTEM, MODEL: DC 4006?

D-CLOT THROMBECTOMY CATHETER SYSTEM, MODEL: DC 4006 is a medical device that received FDA 510(k) clearance on 2008-12-12. The listed applicant is Artegraft, Inc.. The 510(k) number is K083370.

When did D-CLOT THROMBECTOMY CATHETER SYSTEM, MODEL: DC 4006 receive FDA 510(k) clearance?

D-CLOT THROMBECTOMY CATHETER SYSTEM, MODEL: DC 4006 received FDA 510(k) clearance on 2008-12-12, under 510(k) number K083370.

Who is the listed applicant for D-CLOT THROMBECTOMY CATHETER SYSTEM, MODEL: DC 4006?

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

What is the FDA product code for D-CLOT THROMBECTOMY CATHETER SYSTEM, MODEL: DC 4006?

The FDA product code for D-CLOT THROMBECTOMY CATHETER SYSTEM, MODEL: DC 4006 is QEW.

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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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