Search Results
Found 1 results
510(k) Data Aggregation
K Number
K022212Device Name
PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS
Manufacturer
MENTOR MEDICAL LIMITED
Date Cleared
2003-03-21
(256 days)
Product Code
JOH
Regulation Number
868.5800Why did this record match?
Applicant Name (Manufacturer) :
MENTOR MEDICAL LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To create a percutaneous dilational tracheostomy using guidewire, dilators, and components of this product which allows for tracheal access for airway management.
Device Description
The new kit is designed to permit percutaneous creation of a tracheostomy stoma for subsequent insertion of a size 7, 8 or 9mm tracheostomy tube. The kit contains all of the standard components to which the users are accustomed from use of the Rusch predicate device: scalpel, gauze swabs, needle and cannula, syringe, guidewire, guiding catheter, short pre-dilator and set of serial dilators which are also used for introduction of the tracheostomy tube.
Ask a Question
Page 1 of 1