FDA 510(k)

BEARING NSPVA EMBOLIZATION PARTICLES

K-Number: K130259 · 2013-06-07

Decision Date2013-06-07

Product CodeNAJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

BEARING NSPVA EMBOLIZATION PARTICLES is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2013-06-07 under 510(k) number K130259. 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 BEARING NSPVA EMBOLIZATION PARTICLES?

BEARING NSPVA EMBOLIZATION PARTICLES is a medical device that received FDA 510(k) clearance on 2013-06-07. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K130259.

When did BEARING NSPVA EMBOLIZATION PARTICLES receive FDA 510(k) clearance?

BEARING NSPVA EMBOLIZATION PARTICLES received FDA 510(k) clearance on 2013-06-07, under 510(k) number K130259.

Who is the listed applicant for BEARING NSPVA EMBOLIZATION PARTICLES?

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

What is the FDA product code for BEARING NSPVA EMBOLIZATION PARTICLES?

The FDA product code for BEARING NSPVA EMBOLIZATION PARTICLES is NAJ.

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Related Devices (Code: NAJ)

K233813Bearing nsPVA Express™Merit Medical Systems, Inc.K173871CalliSpheres Embolic Microspheres, 8Spheres Embolic MicrospheresSuzhou Hengrui Callisyn Biomedical Co., Ltd.K100663CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321Boston Scientific Corporation K081768COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLESCook Incorporated K030966CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETERBoston Scientific Corp K021397EMBOSPHERE 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.