HD+12, HD+15— 510(k) K220526
Substantially EquivalentCardioline S.P.A
FDA 510(k) clearance K220526 for HD+12, HD+15, Substantially Equivalent on 2023-05-15. Applicant: Cardioline S.P.A. Device class: 2.
Clearance details
- Applicant
- Cardioline S.P.A
- Product code
- Code DRG
- Device class
- Class 2
- Regulation
- 21 CFR 870.2910
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Trento, IT
Recent devices under product code DRG
view allMore clearances from Cardioline S.P.A
view allAdverse events under product code DRG
product code DRG- Death
- 5
- Total
- 5
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 →
Recalls naming K220526
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K220526.
Data sourced from openFDA. This site is unofficial and independent of the FDA.