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FDA 510(k)

PERCUSURGE GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM

K-Number: K003992 · 2001-06-01

ApplicantPercu Surge, Inc.
Decision Date2001-06-01
Product CodeNFA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PERCUSURGE GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Percu Surge, Inc.. It received FDA 510(k) clearance on 2001-06-01 under 510(k) number K003992. 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 PERCUSURGE GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM?

PERCUSURGE GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM is a medical device that received FDA 510(k) clearance on 2001-06-01. The listed applicant is Percu Surge, Inc.. The 510(k) number is K003992.

When did PERCUSURGE GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM receive FDA 510(k) clearance?

PERCUSURGE GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM received FDA 510(k) clearance on 2001-06-01, under 510(k) number K003992.

Who is the listed applicant for PERCUSURGE GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM?

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

What is the FDA product code for PERCUSURGE GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM?

The FDA product code for PERCUSURGE GUARDWIRE TEMPORARY OCCLUSION AND 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 Percu Surge, 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.

K972777TEMPORARY OCCLUSION BALLOON 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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