Medical Device Manufacturer · US , Rockland , MA

Biosphere Medical, Inc. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2001

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Biosphere Medical, Inc. Cardiovascular ✕

2 devices

1-2 of 2

Cleared Aug 09, 2006

EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135

Cardiovascular · 14d

Cleared Jun 02, 2006

SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX

Cardiovascular · 36d