Cleared Traditional

Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6

K190663 · PAJUNK GmbH Medizintechnologie · Anesthesiology
Jun 2019
Decision
94d
Days
Class 2
Risk

About This 510(k) Submission

K190663 is an FDA 510(k) clearance for the Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6, a Filter, Conduction, Anesthetic (Class II — Special Controls, product code BSN), submitted by PAJUNK GmbH Medizintechnologie (Geisingen, DE). The FDA issued a Cleared decision on June 17, 2019, 94 days after receiving the submission on March 15, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5130.

Submission Details

510(k) Number K190663 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 2019
Decision Date June 17, 2019
Days to Decision 94 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSN — Filter, Conduction, Anesthetic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5130

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