FDA 510(k) Applications Submitted by BIOSPHERE MEDICAL, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K062126 07/26/2006 EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135 BIOSPHERE MEDICAL, INC.
K010026 01/03/2001 EMBOGOLD MICROSPHERE BIOSPHERE MEDICAL, INC.
K113822 12/27/2011 QUADRASPHERE 30 TO 60 BIOSPHERE MEDICAL, INC.
K061171 04/27/2006 SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX BIOSPHERE MEDICAL, INC.
K052742 09/30/2005 HEPASPHERE MICROSPHERES BIOSPHERE MEDICAL, INC.
K021397 05/02/2002 EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION BIOSPHERE MEDICAL, INC.


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