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510(k) K133447

EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES by Celonova Biosciences, Inc. — Product Code NAJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2014
Date Received
November 12, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agents, Embolic, For Treatment Of Uterine Fibroids
Device Class
Class II
Regulation Number
870.3300
Review Panel
OB
Submission Type

Other clearances by Celonova Biosciences, Inc.

  • K141209 — EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES (August 7, 2014)
  • K132675 — EMBOZENE MICROSPHERES (October 3, 2013)
  • K130307 — ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE MICRO (March 4, 2013)
  • K073417 — EMBOZENE MICROSPHERES (December 15, 2008)

Other clearances for product code NAJ

  • K233813 — Bearing nsPVA Express™ (December 21, 2023)
  • K173871 — CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres (September 17, 2018)
  • K130259 — BEARING NSPVA EMBOLIZATION PARTICLES (June 7, 2013)
  • K100663 — CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321 (April 16, 2010)
  • K081768 — COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES (December 23, 2008)
  • K030966 — CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER (September 23, 2003)
  • K021397 — EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMB (November 22, 2002)