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FDA 510(k)

XTD THROMBECTOMY CATHETER, XX CM

K-Number: K021641 · 2002-07-26

ApplicantXtrak Medical, Inc.
Decision Date2002-07-26
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

XTD THROMBECTOMY CATHETER, XX CM is the device name listed in this FDA 510(k) record. The listed applicant is Xtrak Medical, Inc.. It received FDA 510(k) clearance on 2002-07-26 under 510(k) number K021641. 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 XTD THROMBECTOMY CATHETER, XX CM?

XTD THROMBECTOMY CATHETER, XX CM is a medical device that received FDA 510(k) clearance on 2002-07-26. The listed applicant is Xtrak Medical, Inc.. The 510(k) number is K021641.

When did XTD THROMBECTOMY CATHETER, XX CM receive FDA 510(k) clearance?

XTD THROMBECTOMY CATHETER, XX CM received FDA 510(k) clearance on 2002-07-26, under 510(k) number K021641.

Who is the listed applicant for XTD THROMBECTOMY CATHETER, XX CM?

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

What is the FDA product code for XTD THROMBECTOMY CATHETER, XX CM?

The FDA product code for XTD THROMBECTOMY CATHETER, XX CM 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.

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 Xtrak Medical, 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.

K032660XTRAK SUPPORT CATHETERK013473XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X; XTD CONTROL CONSOLE, MODEL # CT0006001; XTD COLLECTION BOTTLE, MODEL

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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