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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 nameCatalyze
ApplicantBioTissue Holdings, Inc.
Clearance track510(k)
Submission numberK253204
DecisionSubstantially Equivalent
Decision date2026-06-05
Date received2025-09-26
Product codeKGN
Device classU
Medical specialtyUnknown
Applicant locationFL, US
SourceopenFDA device

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