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Hancock Jaffe Laboratories, Inc.

File an IDE application with the FDA for the VenoValve U.S. pivotal trial

Delivered by the deadline

AI-assessed · human review in progress Found and assessed by AI from the cited sources. Shown with its evidence; it is not counted in any Kept Score until confirmed.

Announced
12 Feb 2021
Due
31 Mar 2021
Delivered
5 Mar 2021
  • Deadline
  • Met
  • Late
  • Not met
  • Today

What the company said

“expects to file its application with the FDA in the first quarter of 2021 seeking IDE approval for commencing the VenoValve U.S. pivotal trial.”

What we found

Evidence strength A What the grades mean

The company successfully filed its IDE application with the FDA for the VenoValve U.S. pivotal trial on March 5, 2021, which is within the first quarter of 2021.

  • A
    Hancock Jaffe Laboratories, Inc. 10-K filed 2021-03-31 Regulatory filing · published 31 Mar 2021 · retrieved 25 Oct 2026 · kept permanently by the SEC
    “On March 5, 2021 we filed an IDE application with the FDA for the VenoValve U.S. pivotal trial.” ✓ confirmed on the page

Checked 25 Oct 2026.

Commitment DNA

The structured record of this commitment. Fields the company did not state are left blank rather than guessed.

Event type
Regulatory filing
Indicative materiality
Medium rules
Action
File
Deliverable
IDE application for VenoValve U.S. pivotal trial
Where
U.S.
Language
Expected (“expects”, “plans”)
In the company’s control
High
Specificity
High
Depends on
Regulatory

How this entry was checked

  1. Commitment recordedThe company's words were matched word for word against the filing.
  2. First checkAn AI model, Gemini (Google), read the company's later filings and recorded the outcome with a quoted passage.

Not yet confirmed. Shown on the record, but it will not count in any score until it is confirmed. How verification works

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Report an error in this entry Reference: KI-C-2021-NVNO-023761 · Corrections policy

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