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
Cleared
Feb 22, 1989
CURITY CONTINUOUS SPINAL ANESTHESIA TRAY
The Kendal Co.
Anesthesiology
63d
Cleared
Oct 28, 1988
PMT 3721-1 EPIDURAL KIT
Progress Mankind Technology
Anesthesiology
85d
Cleared
Sep 14, 1988
MEDTRONIC EPIDURAL CATHETER KIT MODEL 8716
Medtronic Vascular
Anesthesiology
96d
Cleared
Apr 25, 1988
YANKAUER SUCTION INSTRU./LAYTEX GLOVES/SUCT. CATH.
Medical Repackers Co.
Anesthesiology
27d
Cleared
Apr 21, 1988
AXILLARY BLOCK NEEDLE
Bd Becton Dickinson Vacutainer Systems Preanalytic
Anesthesiology
44d
Cleared
Mar 02, 1988
AIK-100 ANESTHESIA INDUCTION KIT/TRAY
Medical Repackers Co.
Anesthesiology
110d
Cleared
Feb 11, 1988
REGANES DISPOSABLE EPIDURAL ANESTHESIA TRAY
Reganes, Inc.
Anesthesiology
27d
Cleared
Nov 24, 1987
BRACHIAL PLEXUS CATHETER - BP-01200
Arrow Intl., Inc.
Anesthesiology
46d
Cleared
Oct 20, 1987
CONTINUOUS EPIDURAL ANESTH. KITS W/NYLON CATHETERS
Arrow Intl., Inc.
Anesthesiology
22d
Cleared
May 15, 1987
CURITY CONTINUOUS EPIDURAL ANESTHESIA TRAY
The Kendal Co.
Anesthesiology
59d
Cleared
Apr 17, 1986
EPIDURAL ANESTHESIA TRAY
Travenol Laboratories, S.A.
Anesthesiology
43d
Cleared
Dec 23, 1985
EPIDURAL ANESTHESIA TRAY
Omnis Surgical, Inc.
Anesthesiology
41d
Cleared
Jul 15, 1985
REGIONAL ANESTHESIA TRAYS
Concord Laboratories, Inc.
Anesthesiology
116d
Cleared
Jun 14, 1985
VYGON BALLOON FOR IDENTIFICATION OF EPIDURAL 193
Vygon Corp.
Anesthesiology
60d
Cleared
Jan 18, 1985
VAS-CATH CONTINOUS EPIDURAL ANESTH. CATH/KIT/TRAY
Vas-Cath of Canada , Ltd.
Anesthesiology
23d
Cleared
Jul 03, 1984
EPIDURAL TRAYS
Concord Laboratories, Inc.
Anesthesiology
39d
Cleared
Feb 24, 1984
CONTINUOUS EPIDURAL ANESTHES. TRAY
Burron Medical Products, Inc.
Anesthesiology
38d
Cleared
Feb 23, 1984
BRACHIAL PLEXUS ANESTHESIA TRAY
Burron Medical Products, Inc.
Anesthesiology
30d
Cleared
Sep 26, 1983
EPIDURAL SYRINGE
Concord Laboratories, Inc.
Anesthesiology
41d
Cleared
Oct 15, 1982
VYGON EPIDURAL ANAESTHESIA TRAY
Exco, Inc.
Anesthesiology
42d
Cleared
Dec 03, 1981
PERFIX SET FOR EPIDURAL ANESTHESIA W/TUO
Burron Medical Products, Inc.
Anesthesiology
17d
Cleared
Oct 17, 1980
REGIONAL INTRAVENOUS ANESTHESIA KIT
Stanco Medical, Inc.
Anesthesiology
28d
Cleared
Sep 16, 1980
ARROW POSITIVE PLACEMENT CON/EPIDURAL AN
Arrow Intl., Inc.
Anesthesiology
36d
Cleared
Aug 07, 1980
CURITY PARACERVICAL/PUDENDAL BLOCK ANES
The Kendal Co.
Anesthesiology
14d