BIOSENSORS CENTRAL VENOUS CATHETER KITS— 510(k) K002786

Clearance details

Applicant

Sunscope Intl., Inc.

Product code

Code FOZ

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

2000-09-07

Decision date

2000-11-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Newport Beach, CA, US

• K260432 — Ruby Intravascular Catheter2026-09-02
• K260165 — Unimpregnated Central Venous Catheter2026-08-10
• K261041 — ClearSafe Closed System2026-07-10
• K260539 — MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter2026-07-09
• K253235 — Introcan Safety® Deep Access XL IV Catheter2026-05-15

• K983372 — BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP1999-02-05
• K973477 — BIOSENSORS EMBOLECTOMY CATHETER1998-09-04
• K981747 — BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX1998-08-20
• K981745 — BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX1998-07-17
• K911710 — HEPARIN COATED THERMODILUTION CATH & ACCESSORIES1991-10-23

Death

38

Injury

2,290

Malfunction

25,858

Other

11

Total

28,197

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →