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FDA 510(k)

BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC

K-Number: K023691 · 2003-06-04

ApplicantBoston Scientific Epi
Decision Date2003-06-04
Product CodeNFA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Epi. It received FDA 510(k) clearance on 2003-06-04 under 510(k) number K023691. 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 BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC?

BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC is a medical device that received FDA 510(k) clearance on 2003-06-04. The listed applicant is Boston Scientific Epi. The 510(k) number is K023691.

When did BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC receive FDA 510(k) clearance?

BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC received FDA 510(k) clearance on 2003-06-04, under 510(k) number K023691.

Who is the listed applicant for BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC?

The FDA 510(k) record lists Boston Scientific Epi as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC?

The FDA product code for BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC is NFA.

Related Clinical Trials

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Other records listing Boston Scientific Epi 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.

K032884FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH

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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