K000001 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 Scimed, Inc. (Plymouth, US). The FDA issued a Cleared decision on June 5, 2000, 154 days after receiving the submission on January 3, 2000.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3720.
| 510(k) Number | K000001 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 03, 2000 |
| Decision Date | June 05, 2000 |
| Days to Decision | 154 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 |