Anesthesiology
Review Panel
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- Assisted Reproduction DevicesCFR Sub-Part
- Cardiovascular Monitoring DevicesCFR Sub-Part
- Cardiovascular Prosthetic DevicesCFR Sub-Part
- NAJAgents, Embolic, For Treatment Of Uterine Fibroids2Product Code
- 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)
- Clinical Chemistry Test SystemsCFR Sub-Part
- Diagnostic DevicesCFR Sub-Part
- MiscellaneousMiscellaneous
- Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Obstetrical and Gynecological Prosthetic DevicesCFR Sub-Part
- Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Obstetrical and Gynecological Therapeutic DevicesCFR Sub-Part
- Physical Medicine Prosthetic DevicesCFR Sub-Part
- Prosthetic DevicesCFR Sub-Part
- Therapeutic DevicesCFR Sub-Part
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
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- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
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- UnknownReview Panel
CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K100663
- 510(k) Type
- Traditional
- Applicant
- Boston Scientific Corporation
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/16/2010
- Days to Decision
- 39 days
- Submission Type
- Summary