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510(k) K233813

Bearing nsPVA Express™ by Merit Medical Systems, Inc. — Product Code NAJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2023
Date Received
November 30, 2023
Clearance Type
Special
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

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Other clearances for product code NAJ

  • K173871 — CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres (September 17, 2018)
  • K133447 — EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES (February 24, 2014)
  • 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)