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FDA 510(k)

MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM

K-Number: K014223 · 2002-01-25

ApplicantMedtronic Percusurge, Inc.
Decision Date2002-01-25
Product CodeNFA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Percusurge, Inc.. It received FDA 510(k) clearance on 2002-01-25 under 510(k) number K014223. The device is classified under product code NFA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM?

MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM is a medical device that received FDA 510(k) clearance on 2002-01-25. The listed applicant is Medtronic Percusurge, Inc.. The 510(k) number is K014223.

When did MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM received FDA 510(k) clearance on 2002-01-25, under 510(k) number K014223.

Who is the listed applicant for MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM?

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

What is the FDA product code for MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM?

The FDA product code for MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM is NFA.

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 Medtronic Percusurge, 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.

K013913PERCUSURGE GUARDWIRE PLUS TEMPORARY OCCLUSION AND ASPIRATION SYSTEM

Related Devices (Code: NFA)

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.

K073523INTERCEPTOR PLUS CORONARY FILTER SYSTEMSMedtronic, Inc.K073563MODIFICATION TO PROXIS SYSTEMSt Jude MedicalK063785SPIDERFX EMBOLIC PROTECTION DEVICEEv3, Inc.K062870TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03Kensey Nash Corp.K060651PROXIS SYSTEM, MODEL EPS101St Jude MedicalK052523PROXIS SYSTEMVelocimed, 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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