TOP VENULA I.V. CATHETER SET— 510(k) K832624

Clearance details

Applicant

Top Surgical Manufacturers Co.

Product code

Code FOZ

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

1983-08-04

Decision date

1983-11-21

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

• K844343 — TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE1985-01-08
• K843415 — TOP HYPODERMIC SYRINGE LUER LOCK1984-12-07
• K843313 — TOP DISPOSABLE SPINAL NEEDLE1984-09-19
• K843414 — TOP HYPODERMIC SYRINGE PISTON1984-09-07
• K841119 — TOPS DISPOS. INFUSION SET/HEMODIALYSIS1984-04-20

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 →