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FDA 510(k)

TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03

K-Number: K062870 · 2006-10-20

ApplicantKensey Nash Corp.
Decision Date2006-10-20
Product CodeNFA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 is the device name listed in this FDA 510(k) record. The listed applicant is Kensey Nash Corp.. It received FDA 510(k) clearance on 2006-10-20 under 510(k) number K062870. 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 TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03?

TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 is a medical device that received FDA 510(k) clearance on 2006-10-20. The listed applicant is Kensey Nash Corp.. The 510(k) number is K062870.

When did TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 receive FDA 510(k) clearance?

TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 received FDA 510(k) clearance on 2006-10-20, under 510(k) number K062870.

Who is the listed applicant for TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03?

The FDA 510(k) record lists Kensey Nash Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03?

The FDA product code for TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 is NFA.

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Other records listing Kensey Nash Corp. 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.

K103787MEDEOR MATRIXK091192KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XXK091499MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY)K090919KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANEK073519QUICKCAT EXTRACTION CATHETER, MODEL 60090-01K071695KENSEY NASH MACROPORE SHIELD

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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.K060651PROXIS SYSTEM, MODEL EPS101St Jude MedicalK052523PROXIS SYSTEMVelocimed, Inc.K061332FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM)Boston Scientific Corp

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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