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510(k) K894380

DUMON TRACHEOBRONCHIAL STENT by Bryan Corp. — Product Code NWA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1989
Date Received
July 17, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Tracheal, Preformed/Molded
Device Class
Class II
Regulation Number
878.3720
Review Panel
AN
Submission Type

The device is intended to provide support to weakened or constricting airway walls.

Other clearances by Bryan Corp.

  • K002063 — BIOTRACE, MODEL 1730 (August 10, 2000)
  • K913242 — MICROPROCESSED CONTROLLED LAPAROFLATOR (September 25, 1992)
  • K881249 — BAGGISH, HYSTEROSCOPE (July 28, 1988)
  • K854414 — DUMON/HARRELL (March 12, 1986)

Other clearances for product code NWA

  • K243126 — TRACHEOBRONXANE™ DUMON® (October 29, 2024)
  • K213969 — VisionAir Patient-Specific Airway Stent (October 7, 2022)
  • K182743 — Patient-Specific Airway Stent (October 23, 2019)
  • K971509 — ENDOXANE (August 21, 1997)
  • K873742 — HOOD TRACHEAL & TRACHEAL-BRONCHIAL PROSTHESES (October 1, 1987)