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FDA 510(k)

XPRESSWAY RX CATHETER (6F LD-VERISON)

K-Number: K121301 · 2012-07-30

ApplicantKaneka Pharma America, LLC
Decision Date2012-07-30
Product CodeQEZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

XPRESSWAY RX CATHETER (6F LD-VERISON) is the device name listed in this FDA 510(k) record. The listed applicant is Kaneka Pharma America, LLC. It received FDA 510(k) clearance on 2012-07-30 under 510(k) number K121301. The device is classified under product code QEZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XPRESSWAY RX CATHETER (6F LD-VERISON)?

XPRESSWAY RX CATHETER (6F LD-VERISON) is a medical device that received FDA 510(k) clearance on 2012-07-30. The listed applicant is Kaneka Pharma America, LLC. The 510(k) number is K121301.

When did XPRESSWAY RX CATHETER (6F LD-VERISON) receive FDA 510(k) clearance?

XPRESSWAY RX CATHETER (6F LD-VERISON) received FDA 510(k) clearance on 2012-07-30, under 510(k) number K121301.

Who is the listed applicant for XPRESSWAY RX CATHETER (6F LD-VERISON)?

The FDA 510(k) record lists Kaneka Pharma America, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XPRESSWAY RX CATHETER (6F LD-VERISON)?

The FDA product code for XPRESSWAY RX CATHETER (6F LD-VERISON) is QEZ.

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 Kaneka Pharma America, LLC 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.

K192068i-ED COILK170247Lacriflow CLK101839KANEKA PHARMA AMERICA XPRESS-WAY RX

Related Devices (Code: QEZ)

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.

K254035Mayumi™ Thrombectomy SystemMicroVention, Inc., d/b/a Terumo NeuroK261105Powered Aventus Thrombectomy System™Inquis MedicalK262030Aventus Thrombectomy SystemInquis MedicalK253589Liberant™ RX Aspiration CatheterMedtronic Interventional Vascular, Inc.K254208FLOWRUNNER Aspiration SystemExpanse Medical, Inc.K253925Aventus Thrombectomy SystemInquis Medical

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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