CAZ · Class II · 21 CFR 868.5140

FDA Product Code CAZ: Anesthesia Conduction Kit

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.

Leading manufacturers include Arrow Intl., Inc., Kendall Healthcare Products Co. Div.Of Tyco Health and PAJUNK GmbH Medizintechnologie.

155
Total
155
Cleared
129d
Avg days
1976
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Anesthesia Conduction Kit Devices (Product Code CAZ)

155 devices
1–24 of 155
Cleared Feb 13, 2023
Arrow 0.2 Micron Flat Filter, GVS
K222341
Arrow International, LLC
Anesthesiology · 194d
Cleared May 19, 2022
BD Epilor Syringe
K210983
Becton, Dickinson and Company
Anesthesiology · 413d
Cleared Feb 12, 2021
Plastic LOR Syringe
K201356
Jiangsu Caina Medical Co.,Ltd
Anesthesiology · 267d
Cleared Dec 29, 2020
E-Cath STIM acc. Tsui
K202699
PAJUNK GmbH Medizintechnologie
Anesthesiology · 104d
Cleared May 16, 2019
VPC
K190345
PAJUNK GmbH Medizintechnologie
Anesthesiology · 91d
Cleared Oct 04, 2016
Arrow Epidural Catheter Kit
K161075
Teleflexmedical, Inc.
Anesthesiology · 169d
Cleared Jun 26, 2015
Arrow Epidural Catheter Kit
K143581
Teleflexmedical, Inc.
Anesthesiology · 190d
Cleared Sep 14, 2012
CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRINGE KIT
K110053
Smiths Medical Asd, Inc.
Anesthesiology · 616d
Cleared Aug 02, 2012
PERIFUSE CATHETER
K121525
Smiths Medical Asd, Inc.
Anesthesiology · 71d
Cleared Mar 01, 2012
SONOLONG SONO, CURL SONO, NANOLINE, BRAND NAMES CARRYINGSONO/SONOLONG
K113188
PAJUNK GmbH Medizintechnologie
Anesthesiology · 122d
Cleared Jan 24, 2012
CONTIPLEX FX
K113059
B.Braun Medical, Inc.
Anesthesiology · 102d
Cleared Nov 04, 2009
EPIFUSE CATHETER CONNECTOR, MODEL: 4909E
K092657
Smiths Medical Asd, Inc.
Anesthesiology · 68d
Cleared Aug 14, 2009
B. BRAUN CONTIPLEX CONTINUOUS NERVE BLOCK SET
K090995
B.Braun Medical, Inc.
Anesthesiology · 129d
Cleared Oct 28, 2008
PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA: CSF
K082183
PAJUNK GmbH Medizintechnologie
Anesthesiology · 88d
Cleared Oct 27, 2008
PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA OF THE PERIPHERAL PLEXUS: SINGLE SHOT
K082164
PAJUNK GmbH Medizintechnologie
Anesthesiology · 88d
Cleared Jun 20, 2007
CONTIPLEX STIM CONTINUOUS NERVE BLOCK SET
K063282
B.Braun Medical, Inc.
Anesthesiology · 232d
Cleared Jun 07, 2007
PAJUNKS EPILONG SET PEDIATRIC
K062902
PAJUNK GmbH Medizintechnologie
Anesthesiology · 253d
Cleared Jan 12, 2007
PAJUNKS STIMULONG TSUI-METHOD SET
K062900
PAJUNK GmbH Medizintechnologie
Anesthesiology · 107d
Cleared Jun 13, 2006
EPILONG KIT FOR ANESTHESIOLOGY
K060311
PAJUNK GmbH Medizintechnologie
Anesthesiology · 125d
Cleared Feb 04, 2004
PERIFIX CATHETER CONNECTOR
K033952
B.Braun Medical, Inc.
Anesthesiology · 44d
Cleared Oct 01, 2003
PERIFIX CATHETER CONNECTOR
K032144
B.Braun Medical, Inc.
Anesthesiology · 79d
Cleared Jun 19, 2002
STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-05000
K021567
Arrow Intl., Inc.
Anesthesiology · 37d
Cleared Jul 12, 2000
19 GA PLASTIC REINFORCED EPIDURAL CATHETER
K001587
Arrow Intl., Inc.
Anesthesiology · 50d
Cleared Jul 06, 2000
PROLONG, MODELS PL50, PL100, PL150
K001129
Life-Tech Intl., Inc.
Anesthesiology · 90d

About Product Code CAZ - Regulatory Context

510(k) Submission Activity

155 total 510(k) submissions under product code CAZ since 1976, with 155 receiving FDA clearance (average review time: 129 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.