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510(k) K033084

WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER by Portex , Ltd. — Product Code MQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2003
Date Received
September 29, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6110
Review Panel
OB
Submission Type

Other clearances by Portex , Ltd.

  • K033080 — PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETER (March 10, 2004)
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  • K032112 — P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED) (January 26, 2004)
  • 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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