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510(k) K073417

EMBOZENE MICROSPHERES by Celonova Biosciences, Inc. — Product Code KRD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2008
Date Received
December 4, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Vascular, For Promoting Embolization
Device Class
Class II
Regulation Number
870.3300
Review Panel
CV
Submission Type

Other clearances by Celonova Biosciences, Inc.

  • K141209 — EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES (August 7, 2014)
  • K133447 — EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES (February 24, 2014)
  • K132675 — EMBOZENE MICROSPHERES (October 3, 2013)
  • K130307 — ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE MICRO (March 4, 2013)

Other clearances for product code KRD

  • K253511 — Concerto Versa™ Detachable Coil (January 14, 2026)
  • K253677 — Tembo Embolic System (December 15, 2025)
  • K253376 — OBSIDIO™ Conformable Embolic (M0013972101010) (October 30, 2025)
  • K250209 — Polyvinyl Alcohol Embolic Microspheres (September 23, 2025)
  • K250133 — HARBOR Occlusion Device (July 9, 2025)
  • K251383 — Prestige Coil System (Prestige Packing Line Extension) (May 30, 2025)
  • K250971 — Embosphere Microspheres (May 16, 2025)
  • K250276 — Nitinol Enhanced Device (NED) (May 15, 2025)
  • K250079 — Ruby XL System (March 14, 2025)
  • K242608 — Embozene Color-Advanced Microspheres (January 17, 2025)