Certa Catheter

FDA 510(k) K171193 · Ferrosan Medical Devices Sp. Z.O.O.

Substantially Equivalent

510(k) numberK171193

Submission

Device name
Certa Catheter
Applicant
Ferrosan Medical Devices Sp. Z.O.O.
Szczecin, PL
Received
April 24, 2017
Decision date
December 18, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BSO – Catheter, Conduction, Anesthetic
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5120
Specialty
Anesthesiology

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K173541EpinautBSO · Traditional Imedicom Co., Ltd.08/24/2018SE
K172777Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7BSO · Traditional PAJUNK GmbH Medizintechnologie05/03/2018SE
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Questions and answers

When was Certa Catheter cleared by the FDA?

Certa Catheter (K171193) received a 510(k) decision of Substantially Equivalent on December 18, 2017, 238 days after the submission was received.

What is the product code of K171193?

The FDA product code is BSO – Catheter, Conduction, Anesthetic, a Class II (moderate risk) device regulated under 21 CFR 868.5120.