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FDA 510(k)

COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES

K-Number: K081768 · 2008-12-23

ApplicantCook Incorporated
Decision Date2008-12-23
Product CodeNAJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2008-12-23 under 510(k) number K081768. The device is classified under product code NAJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES?

COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES is a medical device that received FDA 510(k) clearance on 2008-12-23. The listed applicant is Cook Incorporated. The 510(k) number is K081768.

When did COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES receive FDA 510(k) clearance?

COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES received FDA 510(k) clearance on 2008-12-23, under 510(k) number K081768.

Who is the listed applicant for COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES?

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

What is the FDA product code for COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES?

The FDA product code for COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES is NAJ.

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Related Devices (Code: NAJ)

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.

K233813Bearing nsPVA Express™Merit Medical Systems, Inc.K173871CalliSpheres Embolic Microspheres, 8Spheres Embolic MicrospheresSuzhou Hengrui Callisyn Biomedical Co., Ltd.K130259BEARING NSPVA EMBOLIZATION PARTICLESMerit Medical Systems, Inc.K100663CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321Boston Scientific CorporationK030966CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETERBoston Scientific CorpK021397EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATIONBiosphere Medical, Inc.

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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