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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

by B. Braun Melsungen AG

510(k) K111236

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K111236↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK111236 Date30 Aug 2011ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1397-2025 FDA Class II initiated 17 Feb 2025

    Increased risk for valve housing detachment causing leakage.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
FOZ
FDA applicant
B.Braun Melsungen AG
Device Class
Class II
Regulation
21 CFR Part 880.5200
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Introcan Safety 3 Closed IV Catheter is a closed intravenous catheter system designed for safe and secure venous access. It features a needle-free connector to reduce the risk of needle-stick injuries while maintaining a sterile pathway for fluid administration, blood sampling, or medication delivery.

This device is intended for single-use in hospital settings and is supplied sterile. Available in gauges 18 and 20 with lengths of 1-3/4" (45mm), 1-1/4" (32mm), and 1" (32mm), it complies with FDA 510(k) clearance under K111236 and is also authorised under the Medical Device Regulation (MDR). Storage requires adherence to manufacturer guidelines to preserve sterility.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What are the key safety features of the Introcan Safety 3 Closed IV Catheter that make it different from traditional IV catheters?

    The Introcan Safety 3 features a needle-free connector, which eliminates the risk of needle-stick injuries during fluid administration, blood sampling, or medication delivery. This design maintains a sterile pathway while reducing occupational hazards for healthcare providers.

  • Is this catheter reusable, or is it meant for single-use only?

    The Introcan Safety 3 is explicitly designed for single-use in hospital settings. This ensures sterility and safety, as reuse could compromise the integrity of the sterile pathway and increase infection risks.

  • What sizes and gauges are available for the Introcan Safety 3, and how do they differ?

    The catheter is available in three gauge-length combinations: 18GA with lengths of 1-3/4