# K131666: Arterial HLS Cannula 13 FR Non-Coated, with Bioline Coating and with Softline Coating

- Pathway: 510(k) (Special)
- Applicant: Maquet Cardiopulmonary, AG
- Decided: Jul 5, 2013 after 28 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K922933 (1992). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102532: HLS Cannula Non-Coated, with Bioline Coating and with Softline Coating, Maquet Cardiopulmonary, AG (2011) Summary page 2.
- K924642: Medtronic Bio-Medicus Femoral Cannula/Introducer, Medtronic Bio-Medicus, Inc. (1993) Summary page 2.

## Recalls of this device
- Jul 31, 2026 · Class II · Z-3146-2026: The packaging may not consistently maintain sterile barrier integrity.
- Jul 31, 2026 · Class II · Z-3144-2026: The packaging may not consistently maintain sterile barrier integrity.
- Jul 31, 2026 · Class II · Z-3145-2026: The packaging may not consistently maintain sterile barrier integrity.

## Indications for use
The HLS Cannula from MAOUET is intended for use by trained physicians only. The HLS Cannula may be utilized to cannulate suitable vessels to provide circulatory perfusion of organs and vessels by forming a connection with the extracorporeal circulation. Standard surgical or percutaneous insertion techniques can be employed. This product is intended for use up to six hours or less.

Source page: https://510kreport.com/device/K131666
Methodology: https://510kreport.com/methodology