FDA 510(k)

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

K-Number: K111236 · 2011-08-30

Decision Date2011-08-30

Product CodeFOZ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

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 is the device name listed in this FDA 510(k) record. The listed applicant is B.Braun Melsungen AG. It received FDA 510(k) clearance on 2011-08-30 under 510(k) number K111236. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 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?

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 is a medical device that received FDA 510(k) clearance on 2011-08-30. The listed applicant is B.Braun Melsungen AG. The 510(k) number is K111236.

When did 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 receive FDA 510(k) clearance?

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 received FDA 510(k) clearance on 2011-08-30, under 510(k) number K111236.

Who is the listed applicant for 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?

The FDA 510(k) record lists B.Braun Melsungen AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 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?

The FDA product code for 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 is FOZ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.