PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30— 510(k) K090555
Substantially EquivalentMaquet Cardiopulmonary, AG
FDA 510(k) clearance K090555 for PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30, Substantially Equivalent on 2009-12-23. Applicant: Maquet Cardiopulmonary, AG. Device class: 2.
Clearance details
- Applicant
- Maquet Cardiopulmonary, AG
- Product code
- Code DTR
- Device class
- Class 2
- Regulation
- 21 CFR 870.4240
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hirrlingen, DE
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More 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 DTR
product code DTR- Other
- 1
- Total
- 1
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 K090555
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 K090555.
Data sourced from openFDA. This site is unofficial and independent of the FDA.