{"filing":{"accession_number":"0001437749-26-032887","cik":"0000925741","ticker":"BCDA","company_name":"BioCardia, Inc.","form":"8-K","filing_date":"2026-10-19","report_date":"2026-10-19","primary_document":"bcda20261018_8k.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/925741/000143774926032887/bcda20261018_8k.htm"},"events":[{"id":36003,"run_id":33192,"accession_number":"0001437749-26-032887","anchor_item_number":"8.01","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"summary":"BioCardia announced FDA acceptance of its De Novo pre-submission package for the Helix catheter, with substantive review and a meeting expected this quarter. This is a material regulatory milestone in the product development pathway that would affect investor assessment of the company's progress toward commercialization. While not a final approval, FDA acceptance of the pre-submission and commitment to substantive review represents a significant operational and regulatory advancement for a medical device company.","company_name":"BioCardia, Inc.","ticker":"BCDA","filing_date":"2026-10-19","form":"8-K","submitted_at":null,"items":[{"id":40269,"accession_number":"0001437749-26-032887","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"BioCardia announced FDA acceptance of its De Novo pre-submission package for the Helix catheter, with substantive review and a meeting expected this quarter. This is a material regulatory milestone in the product development pathway that would affect investor assessment of the company's progress toward commercialization. While not a final approval, FDA acceptance of the pre-submission and commitment to substantive review represents a significant operational and regulatory advancement for a medical device company.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-10-19T13:16:37.414305+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":40269,"accession_number":"0001437749-26-032887","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"BioCardia announced FDA acceptance of its De Novo pre-submission package for the Helix catheter, with substantive review and a meeting expected this quarter. This is a material regulatory milestone in the product development pathway that would affect investor assessment of the company's progress toward commercialization. While not a final approval, FDA acceptance of the pre-submission and commitment to substantive review represents a significant operational and regulatory advancement for a medical device company.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-10-19T13:16:37.414305+00:00","company_name":"BioCardia, Inc.","ticker":"BCDA","filing_date":"2026-10-19"}]}