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510(k) K864200

VETA/VENTED ESOPHAGEAL TUBE AIRWAY by Cranco Co. — Product Code CAO

K864200 is an FDA 510(k) premarket notification submitted by Cranco Co. for the device "VETA/VENTED ESOPHAGEAL TUBE AIRWAY". The FDA issued a decision of Substantially Equivalent on March 17, 1987. The device falls under product code CAO (Airway, Esophageal (Obturator)), a Class II device regulated under 21 CFR 868.5650.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1987
Date Received
October 27, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Airway, Esophageal (Obturator)
Device Class
Class II
Regulation Number
868.5650
Review Panel
AN
Submission Type

Other clearances for product code CAO

  • K971348 — FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM (February 27, 1998)
  • K894032 — EVAC-TUBE (August 31, 1989)
  • K875226 — ESOPHAGEAL OBTURATOR/TRACHEAL TUBE (January 19, 1988)
  • K863172 — RESPIRONICS PTL REVIVEEASY (November 4, 1986)
  • K761195 — ESOPHAGEAL OBTURATION AIRWAY (December 9, 1976)

FDA data resources