Cleared Traditional

Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7

K172777 · PAJUNK GmbH Medizintechnologie · Anesthesiology
May 2018
Decision
231d
Days
Class 2
Risk

About This 510(k) Submission

K172777 is an FDA 510(k) clearance for the Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7, 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 May 3, 2018, 231 days after receiving the submission on September 14, 2017. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5120.

Submission Details

510(k) Number K172777 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 2017
Decision Date May 03, 2018
Days to Decision 231 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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