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510(k) K801005

MLT TUBE MICROLARYNGEAL TRACHEAL TUBE) by National Catheter Co. Div. Mallinckrodt — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1980
Date Received
April 28, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheal (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5730
Review Panel
AN
Submission Type

Other clearances by National Catheter Co. Div. Mallinckrodt

  • K802918 — ANTHRON CATHETER SET (April 21, 1981)
  • K802505 — DOUBLE LUMEN TRACHEAL TUBE (March 13, 1981)
  • K810321 — REINFORCED TRACHEOSTOMY TUBE SET(TENTAT) (March 4, 1981)
  • K801924 — HI-LO TEMP GEN. PURPOSE TEMP. PROBE (September 9, 1980)
  • K791190 — STETHOSCOPE WITH TEMPERATURE SENSOR (July 6, 1979)
  • K781665 — TUBE, LEATHERMAN/IMBRUCE (December 15, 1978)
  • K770727 — MANIPULATOR & INJECTOR, UTERINE (April 26, 1977)

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  • K233341 — Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, (May 20, 2024)
  • K223130 — Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP ( (August 30, 2023)