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FDA 510(k)

PRONTO V3 EXTRACTION CATHETER, MODEL 5003

K-Number: K063371 · 2006-12-14

ApplicantVascular Solutions, Inc.
Decision Date2006-12-14
Product CodeQEZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRONTO V3 EXTRACTION CATHETER, MODEL 5003 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 2006-12-14 under 510(k) number K063371. 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 PRONTO V3 EXTRACTION CATHETER, MODEL 5003?

PRONTO V3 EXTRACTION CATHETER, MODEL 5003 is a medical device that received FDA 510(k) clearance on 2006-12-14. The listed applicant is Vascular Solutions, Inc.. The 510(k) number is K063371.

When did PRONTO V3 EXTRACTION CATHETER, MODEL 5003 receive FDA 510(k) clearance?

PRONTO V3 EXTRACTION CATHETER, MODEL 5003 received FDA 510(k) clearance on 2006-12-14, under 510(k) number K063371.

Who is the listed applicant for PRONTO V3 EXTRACTION CATHETER, MODEL 5003?

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 PRONTO V3 EXTRACTION CATHETER, MODEL 5003?

The FDA product code for PRONTO V3 EXTRACTION CATHETER, MODEL 5003 is QEZ.

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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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