HemoSphere Stream Module— 510(k) K253034
Substantially EquivalentEdwards Lifesciences
FDA 510(k) clearance K253034 for HemoSphere Stream Module, Substantially Equivalent on 2025-10-21. Applicant: Edwards Lifesciences. Device class: 2.
Clearance details
- Applicant
- Edwards Lifesciences
- Product code
- Code DQK
- Device class
- Class 2
- Regulation
- 21 CFR 870.1425
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Irvine, CA, US
Recent devices under product code DQK
view allMore clearances from Edwards Lifesciences
view all- K254232 — ECLIPTIS Left Atrial Appendage Exclusion System (4 models)
- K260105 — Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts
- K254279 — Edwards eSheath+ introducer set
- K252533 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)
- K252364 — Edwards eSheath Optima introducer set
Adverse events under product code DQK
product code DQK- Death
- 10
- Injury
- 225
- Malfunction
- 2,123
- Other
- 2
- Total
- 2,360
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.