CATHETERS, OVER-THE-NEEDLE— 510(k) K770751

Clearance details

Applicant

Cutter Laboratories, Inc.

Product code

Code FOZ

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

1977-04-25

Decision date

1977-05-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Walker, MI, US

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• K861315 — HYPERBARIC PENETRATION EXTENSION SET1986-05-21
• K854106 — BAYSILEX1986-03-17
• K842324 — PERFOURM1984-11-09
• K834106 — INTRAVENOUS INFUSION CONTROLLER1984-05-30
• K832237 — ORTHOPEDIC CASTING TAPE MAXCAST1983-08-16

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 →