| SPCL |
SPECIAL TEST FEATURES |
FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN |
| CXCY |
PART NAME ASSIGNED BY CONTROLLING AGENCY |
TRACHEOBRONCHIAL STENT GRAFT |
| FTLD |
FUNCTIONAL DESCRIPTION |
TRACHEAL PROSTHESIS |
| SUPP |
SUPPLEMENTARY FEATURES |
510(K) NUMBER K021901;REGULATORY CLASS II;INTERIOR TUBE OF THE COXIAL 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 |
| ABHP |
OVERALL LENGTH |
70.0 MILLIMETERS NOMINAL |
| ADAV |
OVERALL DIAMETER |
12.0 MILLIMETERS NOMINAL |
| TEXT |
GENERAL CHARACTERISTICS ITEM DESCRIPTION |
WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM |
| FEAT |
SPECIAL FEATURES |
WALLGRAFT PACKAGE;STENT GRAFT DIAMETER 12MM;STENT GRAFT LENGTH 70MM;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 |
| AGAV |
END ITEM IDENTIFICATION |
GENERAL AND PLASTIC SURGERY |
| RDAL |
REFERENCE DATA AND LITERATURE |
21 CFR 878.3720 |