Common Stock
- Symbol
- BCDA
- Exchange
- NASDAQ
- Classification
- COMMON
- Status
- Current
Current Report · Items 8.01, 9.01 · 8-K
BioCardia, Inc.
BCDANASDAQEQUITYCurrent
Other Events
Item 8.01 Other Events. On October 1, 2026, BioCardia, Inc. issued a press release that reported it has completed its revised Pre-Submission to FDA Center for Devices and Radiological Health (CDRH) under its Q-Submission program for the approval of its Helix Catheter for therapeutic and diagnostic agent delivery to the heart.…
Press release in this filing
BioCardia Files Revised De Novo Pre-Submission for FDA Approval of Helix™ Catheter →Company context
Current securities
Historical securities (1)
Registered securities in this filing
BIOCARDIA, INC. · 8-K · Filed 2026-10-01
Disclosure sections
Item 8.01Item 8.01 - Other Events
Item 8.01 Other Events.
On October 1, 2026, BioCardia, Inc. issued a press release that reported it has completed its revised Pre-Submission to FDA Center for Devices and Radiological Health (CDRH) under its Q-Submission program for the approval of its Helix Catheter for therapeutic and diagnostic agent delivery to the heart.
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.