HEMOCONCENTRATOR— 510(k) K123288
Substantially EquivalentMaquet Cardiopulmonary, AG
FDA 510(k) clearance K123288 for HEMOCONCENTRATOR, Substantially Equivalent on 2013-06-26. Applicant: Maquet Cardiopulmonary, AG. Device class: 2.
Clearance details
- Applicant
- Maquet Cardiopulmonary, AG
- Product code
- Code KDI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5860
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rastatt De-Bw, DE
Recent devices under product code KDI
view allMore clearances from Maquet Cardiopulmonary, AG
view all- K150267 — QUADROX-i Adult/Small Adult Oxygenators; QUADROX-iD Adult Oxygenators
- K140569 — ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE)
- K141432 — NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH
- K133598 — CARDIOHELP SYSTEM
- K133265 — QUADROX-IR ADULT AND SMALL ADULT
Adverse events under product code KDI
product code KDI- Death
- 352
- Injury
- 1,474
- Malfunction
- 12,534
- Other
- 4
- Total
- 14,364
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.