MDC SAFE STEP SAFETY I.V. CATHETER SYSTEM— 510(k) K960013

Clearance details

Applicant

MDC Research , Ltd.

Product code

Code FOZ

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

1996-01-02

Decision date

1996-02-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Ventura, CA, US

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• K022959 — SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-12003-02-05
• K973012 — MDC SAFE STEP SAFETY BLOOD COLLECTION NEEDLE SYSTEM1997-11-05

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 →