K963241 is an FDA 510(k) clearance for the ULTRAFLEX. This device is classified as a Prosthesis, Tracheal, Expandable (Class II - Special Controls, product code JCT).
Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on November 14, 1996, 87 days after receiving the submission on August 19, 1996.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3720.
| 510(k) Number | K963241 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Third Party Review (ST) |
| Date Received | August 19, 1996 |
| Decision Date | November 14, 1996 |
| Days to Decision | 87 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 |