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FDA 510(k)

EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION

K-Number: K021397 · 2002-11-22

ApplicantBiosphere Medical, Inc.
Decision Date2002-11-22
Product CodeNAJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION is the device name listed in this FDA 510(k) record. The listed applicant is Biosphere Medical, Inc.. It received FDA 510(k) clearance on 2002-11-22 under 510(k) number K021397. 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 EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION?

EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION is a medical device that received FDA 510(k) clearance on 2002-11-22. The listed applicant is Biosphere Medical, Inc.. The 510(k) number is K021397.

When did EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION receive FDA 510(k) clearance?

EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION received FDA 510(k) clearance on 2002-11-22, under 510(k) number K021397.

Who is the listed applicant for EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION?

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

What is the FDA product code for EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION?

The FDA product code for EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION is NAJ.

Related Clinical Trials

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Other records listing Biosphere Medical, Inc. 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.

K113822QUADRASPHERE 30 TO 60K052742HEPASPHERE MICROSPHERESK062126EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135K061171SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XXK010026EMBOGOLD MICROSPHERE

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 CorporationK081768COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLESCook IncorporatedK030966CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETERBoston Scientific Corp

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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