JOSTRA HLM TUBING SET— 510(k) K053025
Substantially EquivalentMaquet Cardiopulmonary, AG
FDA 510(k) clearance K053025 for JOSTRA HLM TUBING SET, Substantially Equivalent on 2005-11-10. Applicant: Maquet Cardiopulmonary, AG. Device class: 2.
Clearance details
- Applicant
- Maquet Cardiopulmonary, AG
- Product code
- Code DWE
- Device class
- Class 2
- Regulation
- 21 CFR 870.4390
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fairfield, IA, US
Recent devices under product code DWE
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 DWE
product code DWE- Death
- 9
- Malfunction
- 754
- Total
- 763
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 K053025
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 K053025.
Data sourced from openFDA. This site is unofficial and independent of the FDA.