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510(k) K033084

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

K033084 is an FDA 510(k) premarket notification submitted by Portex , Ltd. for the device "WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER". The FDA issued a decision of Substantially Equivalent on December 19, 2003. The device falls under product code MQF (Catheter, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6110. Portex , Ltd. has at least 10 other 510(k) clearances on record.

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)
  • 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)
  • 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)

Other clearances for product code MQF

  • K253354 — Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175 (February 12, 2026)
  • K243373 — Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - (July 23, 2025)
  • K240307 — VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH) (August 16, 2024)
  • K231730 — FemaSeed Intratubal Insemination (September 22, 2023)
  • K220010 — Daylily Single Use Sterile Embryo Transfer Catheter (December 16, 2022)
  • K200248 — Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators (July 1, 2020)
  • K192540 — Kitazato ET Catheters (May 1, 2020)
  • K190522 — Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intr (November 14, 2019)
  • K191015 — Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Cat (May 17, 2019)
  • K180302 — Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, S (October 24, 2018)

FDA data resources