RUSCH POLYFLEX STENT KIT— 510(k) K982614

Substantially Equivalent

Rusch Intl.

FDA 510(k) clearance K982614 for RUSCH POLYFLEX STENT KIT, Substantially Equivalent on 1998-12-04. 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: 1998-07-27
Decision date: 1998-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jeffrey, NH, US

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Recent devices under product code NYT

K013266 — RUSCH POLYFLEX STENT KIT2001-11-27
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.