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510(k) K921353

NASOPHARYNGEAL AIRWAY by Coast Medical Corp. — Product Code BTQ

K921353 is an FDA 510(k) premarket notification submitted by Coast Medical Corp. for the device "NASOPHARYNGEAL AIRWAY". The FDA issued a decision of Substantially Equivalent on June 11, 1992. The device falls under product code BTQ (Airway, Nasopharyngeal), a Class I device regulated under 21 CFR 868.5100. Coast Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1992
Date Received
March 19, 1992
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 Coast Medical Corp.

  • K952243 — EXTENSION SET/I.V. SET (July 26, 1995)
  • K930929 — ESOPHAGEAL STETHOSCOPE (March 17, 1995)
  • K944729 — STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE (December 21, 1994)
  • K943270 — SURFACE TEMPERATURE PROBES (December 5, 1994)
  • K943495 — DISPOSABLE ESOPHAGEAL STETHOSCOPE (September 8, 1994)
  • K943110 — GAS SAMPLING INTERFACES (August 19, 1994)
  • K930930 — COAST MEDICAL, INC. RECTAL PROBE (February 25, 1994)
  • K925781 — DISPOSABLE CUFFED ENDOTRACHEAL TUBE (April 19, 1993)
  • K925855 — DISPOSABLE UNCUFFED ENDOTRACHEAL TUBE (February 18, 1993)
  • K921077 — DISPOSABLE INTUBATION KITS (August 25, 1992)

Other clearances for product code BTQ

  • K940320 — AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS (September 19, 1995)
  • 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)
  • K850644 — NASOPHARYNGEAL AIRWAY-ROBERTAZZI (March 21, 1985)

FDA data resources