The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Ivs Tunneller.
| Device ID | K010035 | 
| 510k Number | K010035 | 
| Device Name: | IVS TUNNELLER | 
| Classification | Mesh, Surgical, Polymeric | 
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 | 
| Contact | Chester Mccoy | 
| Correspondent | Chester Mccoy UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 | 
| Product Code | FTL | 
| CFR Regulation Number | 878.3300 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2001-01-04 | 
| Decision Date | 2001-04-04 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  IVS TUNNELLER  77321440  3453480 Dead/Cancelled | Covidien AG 2007-11-05 | 
|  IVS TUNNELLER  76304799  not registered Dead/Abandoned | Sherwood Services AG 2001-08-24 |