K945494 is an FDA 510(k) clearance for the WALLSTENT(R) TRACHEOBRONCHIAL ENDOPROSTHESIS. 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 March 3, 1995, 115 days after receiving the submission on November 8, 1994.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3720.
| 510(k) Number | K945494 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Third Party Review (ST) |
| Date Received | November 08, 1994 |
| Decision Date | March 03, 1995 |
| Days to Decision | 115 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | JCT — Prosthesis, Tracheal, Expandable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3720 |