510(k) K033080

PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETER by Portex, Inc. — Product Code CAZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 10, 2004
Date Received: September 29, 2003
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Anesthesia Conduction Kit
Device Class: Class II
Regulation Number: 868.5140
Review Panel: AN
Submission Type

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.

Other clearances by Portex, Inc.

K040014 — PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTROD (February 13, 2004)
K032112 — P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED) (January 26, 2004)
K033084 — WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER (December 19, 2003)
K032716 — PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERI (November 28, 2003)
K030570 — BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE (September 17, 2003)
K030381 — PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA (August 27, 2003)
K031057 — PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT (July 18, 2003)
K031622 — WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS (June 26, 2003)
K023793 — 1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR (February 11, 2003)
K014115 — 1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX (February 27, 2002)

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