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FDA 510(k)

XL EXTRACTION CATHETER

K-Number: K112571 · 2011-10-06

ApplicantVascular Solutions, Inc.
Decision Date2011-10-06
Product CodeQEZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

XL EXTRACTION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Solutions, Inc.. It received FDA 510(k) clearance on 2011-10-06 under 510(k) number K112571. 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 XL EXTRACTION CATHETER?

XL EXTRACTION CATHETER is a medical device that received FDA 510(k) clearance on 2011-10-06. The listed applicant is Vascular Solutions, Inc.. The 510(k) number is K112571.

When did XL EXTRACTION CATHETER receive FDA 510(k) clearance?

XL EXTRACTION CATHETER received FDA 510(k) clearance on 2011-10-06, under 510(k) number K112571.

Who is the listed applicant for XL EXTRACTION CATHETER?

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

What is the FDA product code for XL EXTRACTION CATHETER?

The FDA product code for XL EXTRACTION CATHETER is QEZ.

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Other records listing Vascular Solutions, Inc. as applicant

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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

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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