ANTHRON CATHETER SET— 510(k) K802918

Clearance details

Applicant

National Catheter Co. Div. Mallinckrodt

Product code

Code FOZ

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

1980-11-19

Decision date

1981-04-21

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, 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

• K802505 — DOUBLE LUMEN TRACHEAL TUBE1981-03-13
• K810321 — REINFORCED TRACHEOSTOMY TUBE SET(TENTAT)1981-03-04
• K801924 — HI-LO TEMP GEN. PURPOSE TEMP. PROBE1980-09-09
• K801005 — MLT TUBE MICROLARYNGEAL TRACHEAL TUBE)1980-05-23
• K791190 — STETHOSCOPE WITH TEMPERATURE SENSOR1979-07-06

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 →