E-Cath

FDA 510(k) K152952 · PAJUNK GmbH Medizintechnologie

Substantially Equivalent

510(k) numberK152952

Submission

Device name
E-Cath
Applicant
PAJUNK GmbH Medizintechnologie
Geisingen, DE
Received
October 6, 2015
Decision date
July 13, 2016
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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Questions and answers

When was E-Cath cleared by the FDA?

E-Cath (K152952) received a 510(k) decision of Substantially Equivalent on July 13, 2016, 281 days after the submission was received.

What is the product code of K152952?

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