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FDA 510(k)

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

K-Number: K032884 · 2004-08-06

ApplicantBoston Scientific Epi
Decision Date2004-08-06
Product CodeNFA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH 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 2004-08-06 under 510(k) number K032884. 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 FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH?

FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH is a medical device that received FDA 510(k) clearance on 2004-08-06. The listed applicant is Boston Scientific Epi. The 510(k) number is K032884.

When did FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH receive FDA 510(k) clearance?

FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH received FDA 510(k) clearance on 2004-08-06, under 510(k) number K032884.

Who is the listed applicant for FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH?

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 FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH?

The FDA product code for FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K023691BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC

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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