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FDA 510(k) Applications Submitted by PORTEX LTD.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K040014
12/24/2003
PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY
PORTEX LTD.
K030381
02/05/2003
PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA
PORTEX LTD.
K030570
02/24/2003
BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE
PORTEX LTD.
K031622
05/23/2003
WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS
PORTEX LTD.
K032112
07/09/2003
P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED)
PORTEX LTD.
K032716
09/02/2003
PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE)
PORTEX LTD.
K033084
09/29/2003
WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER
PORTEX LTD.
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