Cleared Traditional

VPC

K190345 · PAJUNK GmbH Medizintechnologie · Anesthesiology

May 2019

Decision

91d

Days

Class 2

Risk

About This 510(k) Submission

K190345 is an FDA 510(k) clearance for the VPC, a Anesthesia Conduction Kit (Class II — Special Controls, product code CAZ), submitted by PAJUNK GmbH Medizintechnologie (Geisingen, DE). The FDA issued a Cleared decision on May 16, 2019, 91 days after receiving the submission on February 14, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5140.

Submission Details

510(k) Number	K190345 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 14, 2019
Decision Date	May 16, 2019
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	CAZ — Anesthesia Conduction Kit
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 868.5140
Definition	This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.