K003100 is an FDA 510(k) clearance for the WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM. This device is classified as a Prosthesis, Tracheal, Expandable (Class II - Special Controls, product code JCT).
Submitted by Boston Scientific Corp (Plymouth, US). The FDA issued a Cleared decision on December 20, 2000, 78 days after receiving the submission on October 3, 2000.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3720.
| 510(k) Number | K003100 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 2000 |
| Decision Date | December 20, 2000 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | JCT — Prosthesis, Tracheal, Expandable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3720 |