ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING— 510(k) K131666
Substantially EquivalentMaquet Cardiopulmonary, AG
FDA 510(k) clearance K131666 for ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING, Substantially Equivalent on 2013-07-05. Applicant: Maquet Cardiopulmonary, AG. Device class: 2.
Clearance details
- Applicant
- Maquet Cardiopulmonary, AG
- Product code
- Product code DWF
- Device class
- Class 2
- Regulation
- 21 CFR 870.4210
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hechingen, DE
Recent devices under product code DWF
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 DWF
product code DWF- Death
- 106
- Injury
- 386
- Malfunction
- 2,323
- Total
- 2,815
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 K131666
K-number listed on FDA's recall record- Z-3144-2026 — Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS);
- Z-3145-2026 — Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS);
- Z-3146-2026 — Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA), 701054427 (OUS);
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131666.
Data sourced from openFDA. This site is unofficial and independent of the FDA.