Catalyze — BioTissue Holdings, Inc. (510(k) K253204)
Catalyze — BioTissue Holdings, Inc. (510(k) K253204) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Catalyze; Applicant: BioTissue Holdings, Inc.; Clearance track: 510(k).
| Device name | Catalyze |
|---|---|
| Applicant | BioTissue Holdings, Inc. |
| Clearance track | 510(k) |
| Submission number | K253204 |
| Decision | Substantially Equivalent |
| Decision date | 2026-06-05 |
| Date received | 2025-09-26 |
| Product code | KGN |
| Device class | U |
| Medical specialty | Unknown |
| Applicant location | FL, US |
| Source | openFDA device |
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