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510(k) K953593

RUSCH TRACHEAL BRONCHIAL Y STENT by Rusch, Inc. — Product Code NYT

K953593 is an FDA 510(k) premarket notification submitted by Rusch, Inc. for the device "RUSCH TRACHEAL BRONCHIAL Y STENT". The FDA issued a decision of ST on October 13, 1995. The device falls under product code NYT (Prosthesis, Tracheal, Expandable, Polymeric), a Class II device regulated under 21 CFR 878.3720. Rusch, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
ST ()
Decision Date
October 13, 1995
Date Received
July 31, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Tracheal, Expandable, Polymeric
Device Class
Class II
Regulation Number
878.3720
Review Panel
SU
Submission Type

The device is intended to provide support to weakened or constricting airway walls and indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms or in benign strictures, after all alternative therapies have been exhausted.

Other clearances by Rusch, Inc.

  • K010420 — RUSCH MMG/O'NEIL CATHETER (May 9, 2001)
  • K993528 — RUSCH EMERGENCY MASK (May 31, 2000)
  • K993194 — RUSCH MANUAL RESUSCITATOR BAG (March 24, 2000)
  • K980870 — RUSCH SILICONE FOLEY CATHETER (June 9, 1998)
  • K974419 — RUSCH SIMPLASTIC COUNCILL TIP CATHETER (January 27, 1998)
  • K963779 — RUSCH ENTERAL FEEDING TUBE (May 23, 1997)
  • K970021 — RUSCH SUPRAPUBIC TRAY (February 7, 1997)
  • K963993 — RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET (December 17, 1996)
  • K955564 — RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE (June 28, 1996)
  • K955495 — RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE (June 27, 1996)

Other clearances for product code NYT

  • K013266 — RUSCH POLYFLEX STENT KIT (November 27, 2001)
  • K982614 — RUSCH POLYFLEX STENT KIT (December 4, 1998)

FDA data resources