K964121 is an FDA 510(k) clearance for the WALLSTENT 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 December 4, 1996, 50 days after receiving the submission on October 15, 1996.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3720.
| 510(k) Number | K964121 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Third Party Review (ST) |
| Date Received | October 15, 1996 |
| Decision Date | December 04, 1996 |
| Days to Decision | 50 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 |