B-D HEPARINIZED LONGDWEL I.V. CATHETER— 510(k) K812137

Clearance details

Applicant

Bd Becton Dickinson Vacutainer Systems Preanalytic

Product code

Code FOZ

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

1981-07-28

Decision date

1981-11-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Washington, DC, US

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

• K003062 — BACTEC MGIT 960 SIR KITS2001-06-06
• K003553 — 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE2001-03-21
• K003461 — BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE2001-02-01
• K002938 — B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/162000-11-29
• K001364 — BD DIRECTIGEN FLU A+B2000-06-28

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 →