[{"_1":2,"_3":-5,"_4":-5},"loaderData",{"_5":6,"_7":8},"actionData","errors","root",{"_95":96},"routes/item",{"_9":10},"item",{"_11":12,"_13":14,"_15":16,"_17":18,"_19":20,"_21":-5,"_22":23,"_24":25,"_26":27,"_28":29,"_30":29,"_31":32,"_33":34,"_35":36,"_37":38,"_39":40,"_41":42,"_43":44,"_45":-5,"_46":47,"_48":-5,"_49":-5,"_50":51,"_52":53,"_54":55,"_56":57,"_58":57,"_59":60,"_61":40,"_62":63},"id","krwgaaw0tn23qaymbuqkgufzc","revision",2,"title","BioCardia 8-K 报告","originalTitle","8-K - BioCardia, Inc. (0000925741) (Filer)","summary","BioCardia 于 2026 年 10 月 19 日发布公告，FDA 已接受其 Helix 导管 De Novo 预提交申请，预计本季度进行实质性审查。","reason","source",{"_11":85,"_86":87,"_88":89,"_90":57,"_91":92,"_93":94},"links",{"_82":83,"_63":84},"publishedAt","2026-10-19T13:15:23.000Z","discoveredAt","2026-10-19T13:21:52.385Z","timelineAt","category","tip","tags",[81],"stockSymbols",[80],"score",42,"selected",false,"channel","news","story",{"_72":73,"_15":74},"x","readingMode","full","author","language","body",{"_76":-5,"_63":77,"_78":-5,"_79":40},"outline",[],"relatedStories",[75],"indexable",true,"markdownAvailable","group",{"_64":65,"_43":66,"_67":68,"_69":70,"_71":70},"hasTranslation","bodyLanguage","original","factId","fqWyW0vJtWqw",{"_72":73,"_15":74},"reportCount",1,"additionalSourceCount",0,"developmentCount","publicId","ddda8334-5b00-4ca3-a213-631945015b9a","BioCardia Helix导管De Novo申请获FDA受理",{"_72":73,"_15":74},"zh","

UNITED STATES\n

SECURITIES AND EXCHANGE COMMISSION\n

Washington, D.C. 20549\n

FORM 8-K\n

CURRENT REPORT\n

Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): October 19, 2026\n

BIOCARDIA, INC.\n

\n\n \n \n\n

(Exact name of registrant as specified in its charter)

\n\n \n \n \n \n\n

Delaware

001-38999

23-2753988

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

\n\n \n \n \n \n\n

320 Soquel Way \n
Sunnyvale, California 94085

(Address of principal executive offices and zip code)

Registrant’s telephone number, including area code: (650) 226-0120\n

_____________________________________________

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

\n\n \n \n\n

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

\n\n \n \n\n

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

\n\n \n \n\n

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

\n\n \n \n\n

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

\n\n \n \n \n \n\n

Title of each class

Trading Symbol(s)

Name of each exchange on which

registered

Common Stock, par value $0.001

BCDA

The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2 of this chapter) ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 8.01 Other Events.\n

On October 19, 2026, BioCardia, Inc. issued a press release announcing FDA Acceptance of De Novo Pre-Submission Package for Helix Catheter Marketing Clearance FDA Substantive Review and Meeting Expected this Quarter.

A copy of the press release is attached hereto as Exhibit 99.1 to this current report on Form 8-K.

The information furnished pursuant to this Item 8.01, including Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities under that section, nor shall it be deemed to be incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.\n

(d) Exhibits

\n\n \n \n \n \n \n \n\n

Exhibit No.		Description
99.1		BioCardia, Inc. press release dated October 19, 2026
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES\n

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

\n\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n\n

	BIOCARDIA, INC.

	/s/ Peter Altman, Ph.D.
	Peter Altman, Ph.D.
	President and Chief Executive Officer

	Date: October 19, 2026

","zhKind","complete","BCDA","政策与监管","aihot","/items/krwgaaw0tn23qaymbuqkgufzc","https://www.sec.gov/Archives/edgar/data/925741/000143774926032887/0001437749-26-032887-index.htm","rss-sec-xbrl","name","SEC · EDGAR 财务披露","kind","rss","firstParty","iconUrl","/api/img-proxy?u=https%3A%2F%2Fwww.sec.gov%2Fthemes%2Fcustom%2Fuswds_sec%2Fassets%2Fimg%2Ffavicons%2Fapple-touch-icon.png&mode=avatar&exp=1792627200&sig=564cbec5bb9177d7","iconSrcSet","/api/img-proxy?u=https%3A%2F%2Fwww.sec.gov%2Fthemes%2Fcustom%2Fuswds_sec%2Fassets%2Fimg%2Ffavicons%2Fapple-touch-icon.png&mode=avatar-48&exp=1792627200&sig=034656c278a8477b 48w, /api/img-proxy?u=https%3A%2F%2Fwww.sec.gov%2Fthemes%2Fcustom%2Fuswds_sec%2Fassets%2Fimg%2Ffavicons%2Fapple-touch-icon.png&mode=avatar-96&exp=1792627200&sig=23dae0083a3a8d72 96w","changelogVersion","2026-10-01T08:00"]