Portex, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
27
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K033080PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETERMarch 10, 2004
K040014PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8February 13, 2004
K032112P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED)January 26, 2004
K033084WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETERDecember 19, 2003
K032716PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE)November 28, 2003
K030570BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBESeptember 17, 2003
K030381PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULAAugust 27, 2003
K031057PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KITJuly 18, 2003
K031622WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETSJune 26, 2003
K0237931ST RESPONSE INTERMEDIATE MANUAL RESUSCITATORFebruary 11, 2003
K0141151ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XXFebruary 27, 2002
K014073HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICEFebruary 13, 2002
K873992LARYNGECTOMY TUBEMarch 24, 1988
K874597THERMOVENT 600, 1200, T, 02January 19, 1988
K862167MINI-TRACH KITAugust 6, 1986
K842456JET VENTILATION ADAPTORJuly 6, 1984
K833908IRRI-CATHFebruary 4, 1984
K840015SWIVEL ADAPTOR W/ALARM PORTJanuary 17, 1984
K834565ENDOBRONCHIAL TWIN LUMEN TUBEJanuary 17, 1984
K833189HYDROFLOW SUCTION IRRIGATION SYSTEMNovember 28, 1983