Medical Device Manufacturer · US , Westlake Village , CA

Sunscope Intl., Inc. - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 1991

Recent clearances: BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP, BIOSENSORS EMBOLECTOMY CATHETER, BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX

7

Total

7

Cleared

0

Denied

Sunscope Intl., Inc. has 7 FDA 510(k) cleared medical devices. Based in Westlake Village, US.

Historical record: 7 cleared submissions from 1991 to 2000. Primary specialty: Cardiovascular.

Browse the FDA 510(k) cleared devices submitted by Sunscope Intl., Inc. Filter by specialty or product code using the sidebar.

Sunscope Intl., Inc. is one of 10911 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Sunscope Intl., Inc.

7 devices

1-7 of 7

Cleared Nov 17, 2000

BIOSENSORS CENTRAL VENOUS CATHETER KITS

General Hospital · 71d

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