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- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- NAJAgents, Embolic, For Treatment Of Uterine Fibroids2Product Code
- K233813Bearing nsPVA Express (S100EP); Bearing nsPVA Express (S200EP); Bearing nsPVA Express (S300EP); Bearing nsPVA Express (S400EP); Bearing nsPVA Express (S600EP); Bearing nsPVA Express (S800EP); Bearing nsPVA Express (S1100EP)2Cleared 510(K)
- K173871CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres2Cleared 510(K)
- K133447EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES2Cleared 510(K)
- K130259BEARING NSPVA EMBOLIZATION PARTICLES2Cleared 510(K)
- K100663CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M00176003212Cleared 510(K)
- K081768COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES2Cleared 510(K)
- K030966CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER2Cleared 510(K)
- K021397EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION2Cleared 510(K)
- Subpart D—Obstetrical and Gynecological Prosthetic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart F—Obstetrical and Gynecological Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Assisted Reproduction DevicesCFR Sub-Part
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CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K173871
- 510(k) Type
- Traditional
- Applicant
- Suzhou Hengrui Callisyn Biomedical Co., Ltd.
- Country
- China
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/17/2018
- Days to Decision
- 271 days
- Submission Type
- Summary