SILASTIC INTRAVENOUS CATHETER UNIT— 510(k) K790914

Clearance details

Applicant

Dow Corning Corp. Healthcare Industries Materials

Product code

Code FOZ

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

1979-05-14

Decision date

1979-07-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Walker, MI, 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

• K853186 — SILASTIC INFLATABLE BONE PLUG H.P.1985-09-24
• K844637 — WHITESIDE ACRYLIC CEMENT SPACER SLEEVE1985-06-19
• K850255 — DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMET1985-05-01
• K843995 — TF-II HIP PROSTHESIS1985-04-23
• K842559 — WHITESIDE ORTHOLOC TOTAL HIP FEMORAL1984-12-20

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 →