FDA applicant
Cardioquip Llp
FDA records 1 decision for Cardioquip Llp (Bryan, TX) in 2010: 1 510(k) clearance. All are in product code DWC (Controller, Temperature, Cardiopulmonary Bypass). 9 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Cardioquip Llp’s devices, and how often a recall has named them.
FDA decisions per year
1in 2010
2010high 1 (2010) · low 0 (2011)2026
2026 so far, outlined.
Recalls per year
4in 2023
2010high 5 (2021) · low 0 (2010)2026
Class I Class II/III not classified
Planning a device like Cardioquip Llp’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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