LF CT HIG PRESSURE CATHETERS— 510(k) K945053

Clearance details

Applicant

Mallinckrodt Group, Inc.

Product code

Code FOZ

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

1994-10-14

Decision date

1995-05-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Cincinnati, OH, 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

• K945140 — URO-FLO1995-03-08
• K943581 — HYDRADJUST IV UROLOGICAL TABLE1995-01-04
• K943122 — SURGICAL DRAPES1994-09-07
• K934664 — HYDRAGOWN1994-05-24
• K920742 — HYDRAJUST IV UROLOGICAL TABLE1992-04-27

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 →