{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-25-032150","form_type":"8-K","ticker":"NUWE","cik":"0001506492","company_name":"Nuwellis, Inc.","filed_at":"2025-08-21T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.162879+00:00","generated_at":"2026-05-17T10:48:33.125804+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.55,"calibrated_materiality_score":0.55,"confidence":"high","headline":"Nuwellis gets FDA 510(k) clearance for new catheter size","bullets":["FDA 510(k) clearance received for new size of Nuwellis' Dual Lumen Extended Length Catheter (dELC) on August 21, 2025.","Clearance allows Nuwellis to market the new size catheter in the United States.","No specific dimensions, commercial launch date, or revenue impact disclosed."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-25-032150","json":"https://secwatch.observer/filing/0001140361-25-032150.json","markdown":"https://secwatch.observer/filing/0001140361-25-032150.md","text":"https://secwatch.observer/filing/0001140361-25-032150.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1506492/000114036125032150/0001140361-25-032150-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1506492/000114036125032150/ef20054300_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T10:48:33.125804+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}