Helo Return— 510(k) K253717
Substantially EquivalentEndovascular Engineering, Inc.
FDA 510(k) clearance K253717 for Helo Return, Substantially Equivalent on 2026-10-11. Applicant: Endovascular Engineering, Inc.. Device class: 2.
Summary
Helo Return from Endovascular Engineering is filed under product code CAC, autotransfusion apparatus. The record doesn't describe the device beyond its name, so it isn't clear from the data which part of the autotransfusion process it covers.
Class II, 21 CFR 868.5830. The Cardiovascular review panel handled it as a Traditional 510(k), and the decision was Substantially Equivalent. The record lists Anesthesiology as the classification panel.
Endovascular Engineering filed from Menlo Park, California. The review clock ran 321 days, from November 24, 2025 to October 11, 2026. The record doesn't show how much of that was hold time.
Clearance details
- Applicant
- Endovascular Engineering, Inc.
- Product code
- Product code CAC
- Device class
- Class 2
- Regulation
- 21 CFR 868.5830
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Menlo Park, CA, US
Recent devices under product code CAC
view allMore clearances from Endovascular Engineering, Inc.
view allAdverse events under product code CAC
product code CAC- Death
- 11
- Malfunction
- 477
- Total
- 488
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.