CARDIOHELP SYSTEM— 510(k) K133598
Substantially EquivalentMaquet Cardiopulmonary, AG
FDA 510(k) clearance K133598 for CARDIOHELP SYSTEM, Substantially Equivalent on 2014-05-21. Applicant: Maquet Cardiopulmonary, AG. Device class: 2.
Clearance details
- Applicant
- Maquet Cardiopulmonary, AG
- Product code
- Code DTQ
- Device class
- Class 2
- Regulation
- 21 CFR 870.4220
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wayne, NJ, US
Recent devices under product code DTQ
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
- K133265 — QUADROX-IR ADULT AND SMALL ADULT
- K132166 — VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT
Adverse events under product code DTQ
product code DTQ- Death
- 123
- Malfunction
- 4,822
- Other
- 1
- Total
- 4,946
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 K133598
K-number listed on FDA's recall record- Z-1300-2026 — Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;
- Z-1831-2024 — CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
- Z-1053-2024 — Bubble Sensor (REF: 70105.5720)
- Z-0595-2024 — CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours). Product REF Numbers: 701072780; 701048012
- Z-0605-2024 — Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802
- Z-0555-2024 — CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass Part Number: 701072780, (CARDIOHELP-I US); 701048012 (CARDIOHELP-I NON US)
- Z-0290-2024 — Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
- Z-0420-2024 — CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.
- Z-0897-2022 — Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours). Product Code/REF Number: 701072780 (Cardiohelp-i)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133598.
Data sourced from openFDA. This site is unofficial and independent of the FDA.