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510(k) K903740

TRACH-EZE by Sorex Medical — Product Code BSY

K903740 is an FDA 510(k) premarket notification submitted by Sorex Medical for the device "TRACH-EZE". The FDA issued a decision of Substantially Equivalent on December 6, 1990. The device falls under product code BSY (Catheters, Suction, Tracheobronchial), a Class I device regulated under 21 CFR 868.6810. Sorex Medical has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1990
Date Received
August 16, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheters, Suction, Tracheobronchial
Device Class
Class I
Regulation Number
868.6810
Review Panel
AN
Submission Type

Other clearances by Sorex Medical

  • K923843 — FOGLESS (March 25, 1994)
  • K913036 — PLUME MASTER (September 6, 1991)
  • K911070 — PICC-FIX (July 5, 1991)
  • K911150 — SOREX SAFE-AIR (June 28, 1991)
  • K910315 — PICC INSERTION KIT/P.I.C. & PICC EXCHANG KIT/P.E.K (April 5, 1991)
  • K905572 — EDLICH WOUND MANAGEMENT TRAY (March 12, 1991)
  • K902410 — MEDICAL PROCEDURE TRAY (November 20, 1990)
  • K885136 — GRAFT GUARD (February 6, 1989)

Other clearances for product code BSY

  • K031997 — MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM (November 25, 2003)
  • K992902 — AMBU HAND POWER SUCTION PUMP (October 25, 1999)
  • K982945 — DUAL PURPOSE CLOSED CATHETER (September 22, 1998)
  • K981910 — SUCTION CATHETER (August 24, 1998)
  • K972258 — HI-CARE CLOSED SUCTION SYSTEM (December 29, 1997)
  • K973199 — AMSINO SUCTION CATHETER (September 10, 1997)
  • K961707 — TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM (March 11, 1997)
  • K964369 — TRACH CARE SET WITH MICROBAN (February 11, 1997)
  • K960488 — NEO 2 LINE SUCTION SYSTEM (April 26, 1996)
  • K955831 — ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM (March 28, 1996)

FDA data resources