Home / 510(k) Clearances / K013266

510(k) K013266

RUSCH POLYFLEX STENT KIT by Rusch Intl. — Product Code NYT

K013266 is an FDA 510(k) premarket notification submitted by Rusch Intl. for the device "RUSCH POLYFLEX STENT KIT". The FDA issued a decision of Substantially Equivalent on November 27, 2001. The device falls under product code NYT (Prosthesis, Tracheal, Expandable, Polymeric), a Class II device regulated under 21 CFR 878.3720. Rusch Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 2001
Date Received
October 1, 2001
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 Intl.

  • K033023 — INTERMITTENT URETHRAL CATHETERS (December 23, 2003)
  • K030559 — RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM (June 30, 2003)
  • K023666 — RUSCH GUIDED CHOLANGIOGRAPHY CATHETER (June 17, 2003)
  • K023918 — RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS (March 28, 2003)
  • K023964 — RUSCH MICROLARYNGEAL TUBE (December 23, 2002)
  • K021540 — RUSCH EDGAR TUBE (August 1, 2002)
  • K021764 — RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED (July 23, 2002)
  • K020714 — RUSCH FLONEIL; FLOCATH INTROGEL (July 1, 2002)
  • K010797 — RUSCH MILLER-ABBOTT TUBE (February 26, 2002)
  • K010798 — RUSCH CANTOR TUBE (February 26, 2002)

Other clearances for product code NYT

  • K982614 — RUSCH POLYFLEX STENT KIT (December 4, 1998)
  • K953593 — RUSCH TRACHEAL BRONCHIAL Y STENT (October 13, 1995)

FDA data resources