PROTECTIV 2000 I.V. CATHETER SAFETY SYSTEM— 510(k) K962226

Clearance details

Applicant

Johnson & Johnson Medical, Inc.

Product code

Code FOZ

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

1996-06-10

Decision date

1996-12-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Menlo Park, CA, US

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• K253235 — Introcan Safety® Deep Access XL IV Catheter2026-05-15

• K001690 — PROTECTIV SAFETY BLOOD COLLECTION NEEDLE2000-07-31
• K982641 — ADVANCED NIBP MODULE1999-03-29
• K983362 — NU-GEL * WOUND DRESSING1998-12-16
• K982597 — FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE1998-08-20
• K974080 — CRITIKON SOFT BLOOD PRESSURE CUFF1998-05-18

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 →