Home / 510(k) Clearances / K792018

510(k) K792018

SILICONE RUBBER-BI NASOPHARYNGEAL AIR by Vesta, Inc. — Product Code BTQ

K792018 is an FDA 510(k) premarket notification submitted by Vesta, Inc. for the device "SILICONE RUBBER-BI NASOPHARYNGEAL AIR". The FDA issued a decision of Substantially Equivalent on November 13, 1979. The device falls under product code BTQ (Airway, Nasopharyngeal), a Class I device regulated under 21 CFR 868.5100. Vesta, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1979
Date Received
October 9, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Airway, Nasopharyngeal
Device Class
Class I
Regulation Number
868.5100
Review Panel
AN
Submission Type

Other clearances by Vesta, Inc.

  • K834078 — SILICONE RUGGER DISPOSABLE YOKE-CPAP (December 27, 1983)
  • K810960 — NASOPHARYNGEAL AIRWAY (April 23, 1981)
  • K792719 — 3 WAY URETHRAL IRRIGATION CATHETER (January 16, 1980)

Other clearances for product code BTQ

  • K940320 — AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS (September 19, 1995)
  • K921353 — NASOPHARYNGEAL AIRWAY (June 11, 1992)
  • K911784 — NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY (September 23, 1991)
  • K903618 — ROBERTAZZI NASOPHARYNGEAL AIRWAY (January 8, 1991)
  • K900456 — POLAMEDCO NASOPAHARYNGEAL AIRWAY (April 19, 1990)
  • K901279 — CHATHAM INDUSTRIES NASOPHARYNGEAL AIRWAY (March 28, 1990)
  • K883668 — SUNDERLAND NASAL TUBE (November 21, 1988)
  • K873949 — RORERTAZZI NASOPHARYNGEAL AIRWAY (October 20, 1987)
  • K871673 — NASOPHARYNGEAL AIRWAY (June 15, 1987)
  • K853162 — STERILE NASOPHARYNGEAL AIRWAY (August 6, 1985)

FDA data resources