# K102532: HLS Cannula Non-Coated, with Bioline Coating and with Softline Coating

- Pathway: 510(k) (Traditional)
- Applicant: Maquet Cardiopulmonary, AG
- Decided: Feb 25, 2011 after 175 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K922933 (1992). 21 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924642: Medtronic Bio-Medicus Femoral Cannula/Introducer, Medtronic Bio-Medicus, Inc. (1993) Summary page 1.
- K082117: Quadrox-I Adult with and Without Integrated Arterial Filter with Softline Coating, Model# Hmo 70000, Hmo 71000, Maquet Cardiopulmonary, AG (2009) Summary page 1.
- K090511: Quadrox-I Adult Microporous Membrane Oxygenator with Bioline Coating, Model BEHMO70000,Beq-HMO70000, Maquet Cardiopulmonary, AG (2009) Summary page 1.

## Most influential descendants
- K131666: Arterial HLS Cannula 13 FR Non-Coated, with Bioline Coating and with Softline Coating (2013), 0 descendants of its own

## Indications for use
The HLS Cannula from MAQUET 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/K102532
Methodology: https://510kreport.com/methodology