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510(k) K875226

ESOPHAGEAL OBTURATOR/TRACHEAL TUBE by Sheridan Catheter Corp. — Product Code CAO

K875226 is an FDA 510(k) premarket notification submitted by Sheridan Catheter Corp. for the device "ESOPHAGEAL OBTURATOR/TRACHEAL TUBE". The FDA issued a decision of Substantially Equivalent on January 19, 1988. The device falls under product code CAO (Airway, Esophageal (Obturator)), a Class II device regulated under 21 CFR 868.5650. Sheridan Catheter Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 1988
Date Received
December 22, 1987
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 by Sheridan Catheter Corp.

  • K922894 — LAZER-TRACH TRACHEAL TUBE (May 7, 1993)
  • K897046 — LASER RESISTANT TRACHEAL TUBE (March 23, 1990)
  • K890823 — ACCESSORY TO CLINICAL ELECTRONIC THERMOMETER (May 5, 1989)
  • K884765 — CLINICAL ELECTRONIC THERMOMETERS (February 16, 1989)
  • K882918 — KIM NASO-INTESTINAL TUBE (December 5, 1988)
  • K882127 — CLINICAL ELECTRONIC THERMOMETERS (August 4, 1988)
  • K881368 — CLINICAL ELECTONIC THERMOMETERS (July 13, 1988)
  • K881293 — SHERIDAN ELECTROSURGERY PROTECTION FILTER (June 16, 1988)
  • K881873 — INTRODUCTION/DRAINAGE CATHETER & ACCESS (May 18, 1988)
  • K880960 — NDYAG LASER TRACHEAL TUBE (April 29, 1988)

Other clearances for product code CAO

  • K971348 — FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM (February 27, 1998)
  • K894032 — EVAC-TUBE (August 31, 1989)
  • K864200 — VETA/VENTED ESOPHAGEAL TUBE AIRWAY (March 17, 1987)
  • K863172 — RESPIRONICS PTL REVIVEEASY (November 4, 1986)
  • K761195 — ESOPHAGEAL OBTURATION AIRWAY (December 9, 1976)

FDA data resources