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.

156
Total
156
Cleared
129d
Avg days
1976
Since
156 devices
49–72 of 156
Cleared Jul 16, 2002
AVID-NIT NERVE STIMULATION NEEDLES
K014246
Avid N.I.T., Inc.
Anesthesiology · 202d
Cleared Jun 19, 2002
STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-05000
K021567
Arrow Intl., Inc.
Anesthesiology · 37d
Cleared Jun 11, 2002
PLEXOLONG SETS
K013041
Pajunk GmbH
Anesthesiology · 274d
Cleared Sep 06, 2001
MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/KIT
K012584
Bd
Anesthesiology · 27d
Cleared Oct 13, 2000
CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551-07
K994059
Hdc Corp.
Anesthesiology · 319d
Cleared Aug 11, 2000
MICOR ANESTHESIA CONDUCTION KIT
K001940
Micor, Inc.
Anesthesiology · 46d
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
Cleared Aug 18, 1999
EPISTAR/EPISTAR CSE SPINAL/EPIDURAL ANESTHESIA ADMINISTRATION SETS
K991719
Medimex Holfeld GmbH & Co.
Anesthesiology · 90d
Cleared Nov 17, 1998
EPIDURAL CATHETER MODELS 1210/1200
K983125
Rusch Intl.
Anesthesiology · 70d
Cleared Oct 17, 1997
SOFT TIP EPIDURAL CATHETER KIT
K971233
B.Braun Medical, Inc.
Anesthesiology · 198d
Cleared Apr 03, 1997
PERIFIX PEDIATRIC EPIDURAL KIT
K962696
B.Braun Medical, Inc.
Anesthesiology · 266d
Cleared Mar 14, 1997
REGIONAL ANESTHESIA TRAYS
K965017
Smiths Industries Medical Systems, Inc.
Anesthesiology · 88d
Cleared Feb 12, 1997
EPIDURAL MINI KIT, ELDOR COMBINED SPINAL/EPIDURAL KIT
K964783
Alexander Medical, Inc.
Anesthesiology · 77d
Cleared Dec 09, 1996
SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEM
K962880
Sherwood Medical Co.
Anesthesiology · 138d
Cleared Nov 13, 1996
EPIDURAL ANESTHESIA KIT AND COMBINED SPINAL EPIDURAL ANESTHESIA KIT
K962821
Global Medical Products, Ltd.
Anesthesiology · 117d
Cleared Sep 06, 1996
MEDCARE REGIONAL ANETHESIA KIT
K961075
Medcare Medical Group, Inc.
Anesthesiology · 172d
Cleared Jun 20, 1996
MORE-L INJECTOR KIT PLUS
K960619
Incutech, Inc.
Anesthesiology · 128d
Cleared May 30, 1996
KENDALL BLUNT TUOHY EPIDURAL NEEDLE
K954706
Kendall Healthcare Products Co. Div.Of Tyco Health
Anesthesiology · 231d
Cleared May 20, 1996
B-D DURASAFE COMBINED SPINAL EPIDURAL (CSE) TRAY
K954953
Bd Becton Dickinson Vacutainer Systems Preanalytic
Anesthesiology · 203d
Cleared Apr 24, 1996
SPINAL SPECIALTIES NERVE BLOCK TRAY
K960100
Spinal Specialties, Inc.
Anesthesiology · 104d
Cleared Jan 31, 1996
HOLGRATH COMBINED SPINAL EPIDURAL NEEDLE SET
K954835
Holgrath Medical Technologies, Inc.
Anesthesiology · 103d
Cleared Jan 22, 1996
MORELL INJECTOR
K951870
Incutech, Inc.
Anesthesiology · 276d
Cleared Nov 30, 1995
BD PERISAFE EPIDURAL ANESTHESIA TRAY
K953790
Bd Becton Dickinson Vacutainer Systems Preanalytic
Anesthesiology · 108d