Sunscope Intl., Inc. - FDA 510(k) Cleared Devices
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sunscope Intl., Inc. Cardiovascular ✕
6 devices
Cleared
Feb 05, 1999
BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP
Cardiovascular
134d
Cleared
Sep 04, 1998
BIOSENSORS EMBOLECTOMY CATHETER
Cardiovascular
354d
Cleared
Aug 20, 1998
BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX
Cardiovascular
94d
Cleared
Jul 17, 1998
BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX
Cardiovascular
60d
Cleared
Oct 23, 1991
HEPARIN COATED THERMODILUTION CATH & ACCESSORIES
Cardiovascular
189d
Cleared
Sep 27, 1991
SAFEWEDGE(TM) RELIEF VALVE DEVICE
Cardiovascular
134d