INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4 (45MM) AND 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) / 20GA X 1— 510(k) K111236

Clearance details

Applicant

B.Braun Melsungen AG

Product code

Code FOZ

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

2011-05-02

Decision date

2011-08-30

Decision

Substantially Equivalent

Clearance type

Traditional

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

• K163358 — Introcan Safety 3 Closed IV Catheter2017-04-28
• K152050 — Pencylcap2016-03-02
• K131040 — EXTAVIPRO STERICAN 30G2013-07-15
• K102033 — COMBITRANS MONITORING SETS AND ACCESSORIES2011-04-07

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 K111236.