Search Results
Found 2 results
510(k) Data Aggregation
K Number
K013266Device Name
RUSCH POLYFLEX STENT KIT
Manufacturer
RUSCH INTL.
Date Cleared
2001-11-27
(57 days)
Product Code
NYT
Regulation Number
878.3720Why did this record match?
Product Code :
NYT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Airway complications such as anastomosis ans stenosis, Trachea-esophageal fistula, Stenosis of the central ridence obsphagetee trachea and main bronchus), and arrways (Such as trictures due to tumors (Trachea and main bronchus) .
Compression or strictures due to tumors (trachea and main bronchus) Stenosis of the central airways (such as trachea and main bronchus) Tracheo Esophageal fistula
Airway complications such as-anastomosis and stenosis
Device Description
The Rusch Polyflex Stent Kit consists of a medical silicone file Rusch folyrica beene core along with the components Suppored by insert the device into the human body. These required to inocre one he Introducer Sleeve, the Stent Loader, Soft Positioner, and Blue Stopper.
This amendment changes the material of the Insertion ffirs amending to adds indicator markings to the stent and provides for a non-sterile version.
Ask a Question
K Number
K982614Device Name
RUSCH POLYFLEX STENT KIT
Manufacturer
RUSCH INTL.
Date Cleared
1998-12-04
(130 days)
Product Code
NYT
Regulation Number
878.3720Why did this record match?
Product Code :
NYT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Airway complications such as anastomosis ans stenosis, Trachea-esophageal fistula, Stenosis of the central airways(such as the trachea and main bronchus), and Compression or strictures due to tumors (Trachea and main bronchus) .
Device Description
The Rüsch Polyflex Stent Kit consists of a medical silicone supported by a polyester core along with the components required to insert the device into the human body. These components consist of the Introducer Sleeve, the Stent Loader, Soft Positioner, and Blue Stopper.
Ask a Question
Page 1 of 1