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510(k) K873992

LARYNGECTOMY TUBE by Portex, Inc. — Product Code KAC

K873992 is an FDA 510(k) premarket notification submitted by Portex, Inc. for the device "LARYNGECTOMY TUBE". The FDA issued a decision of Substantially Equivalent on March 24, 1988. The device falls under product code KAC (Tube, Laryngectomy), a Class I device regulated under 21 CFR 874.4420. Portex, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1988
Date Received
October 1, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Laryngectomy
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type

Other clearances by Portex, Inc.

  • 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)
  • 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)

Other clearances for product code KAC

  • K901377 — BARTON-MAYO TRACHEOSTOMA BUTTON (June 14, 1990)
  • K821993 — SHILEY LARYNGECTOMY TUBE (August 12, 1982)
  • K811428 — NORTHWESTERN VOICE RESTORATION KIT (June 16, 1981)

FDA data resources