RUSCH POLYFLEX STENT KIT— 510(k) K013266

Substantially Equivalent

Rusch Intl.

FDA 510(k) clearance K013266 for RUSCH POLYFLEX STENT KIT, Substantially Equivalent on 2001-11-27. Applicant: Rusch Intl.. Device class: 2.

Clearance details

Applicant: Rusch Intl.
Product code: Code NYT
Device class: Class 2
Regulation: 21 CFR 878.3720
Advisory panel: General, Plastic Surgery
Date received: 2001-10-01
Decision date: 2001-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jaffrey, NH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NYT

K982614 — RUSCH POLYFLEX STENT KIT1998-12-04
K953593 — RUSCH TRACHEAL BRONCHIAL Y STENT1995-10-13

More clearances from Rusch Intl.

K033023 — INTERMITTENT URETHRAL CATHETERS2003-12-23
K030559 — RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM2003-06-30
K023666 — RUSCH GUIDED CHOLANGIOGRAPHY CATHETER2003-06-17
K023918 — RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS2003-03-28
K023964 — RUSCH MICROLARYNGEAL TUBE2002-12-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.