| FUNCTIONAL DESCRIPTION | TRACHEAL PROSTHESIS |
| GENERAL CHARACTERISTICS ITEM DESCRIPTION | WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM |
| OVERALL DIAMETER | 12.0 MILLIMETERS NOMINAL |
| OVERALL LENGTH | 50.0 MILLIMETERS NOMINAL |
| PART NAME ASSIGNED BY CONTROLLING AGENCY | TRACHEOBRONCHIAL STENT GRAFT |
| REFERENCE DATA AND LITERATURE | 21 CFR 878.3720 |
| SPECIAL FEATURES | WALLGRAFT PACKAGE;STENT GRAFT DIAMETER 12MM;STENT GRAFT LENGTH 50MM;DELIVERY SYSTEM PROFILE 11F;INDICATIONS FOR USE-TREATMENT OF TRACHEOBRONCIAL STRICTURES PRODUCED BY MALIGNANT NEOPLASMS OR IN BENIGN STRICTURES AFTER ALL ALTERNATIVE THERAPIES HAVE BEEN EXHAUSTED |
| SPECIAL TEST FEATURES | FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN |
| SUPPLEMENTARY FEATURES | 510(K) NUMBER K021901;REGULATORY CLASS II;INTERIOR TUBE OF THE COAXIAL SYSTEM CONTAINS A CENTRAL LUMEN WHICH WILL ACCOMMODATE A 0.035INCH GUIDE WIRE;THE DELIVERY SYSTEM WILL BE AVAILABLE IN A SINGLE WORKING LENGTH OF 90CM |