Cleared Traditional

E-Cath

K152952 · PAJUNK GmbH Medizintechnologie · Anesthesiology
Jul 2016
Decision
281d
Days
Class 2
Risk

About This 510(k) Submission

K152952 is an FDA 510(k) clearance for the E-Cath, a Catheter, Conduction, Anesthetic (Class II — Special Controls, product code BSO), submitted by PAJUNK GmbH Medizintechnologie (Geisingen, DE). The FDA issued a Cleared decision on July 13, 2016, 281 days after receiving the submission on October 6, 2015. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5120.

Submission Details

510(k) Number K152952 FDA.gov
FDA Decision Cleared SESE
Date Received October 06, 2015
Decision Date July 13, 2016
Days to Decision 281 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSO — Catheter, Conduction, Anesthetic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5120

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