Introcan Safety 3 Closed IV Catheter— 510(k) K213085

Clearance details

Applicant

B.Braun Medical, Inc.

Product code

Code FOZ

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

2021-09-24

Decision date

2021-10-25

Decision

Substantially Equivalent

Clearance type

Special

Location

Allentown, PA, 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

• K254111 — Irrigation/Urology Sets2026-09-10
• K243392 — Infusomat® Space Volumetric Infusion Pump Administration Sets2025-07-24
• K240578 — VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System2024-07-31
• K241845 — Introcan Safety® 2 IV Catheter2024-07-26
• K241385 — Omnifix Syringe NRFit2024-07-13

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 →

• Z-1397-2025 — Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.Class II·Ongoing·B Braun Medical Inc·20250217

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K213085.