# K061743: Venous Hardshell Cardiotomy Reservoir W/Safeline Coating, Model BSQ-VHK 2000;Vacuum Tight, Model BSQ-VHK 2001

- Pathway: 510(k) (Special)
- Applicant: Maquet Cardiopulmonary, AG
- Decided: Jul 21, 2006 after 30 days
- Product code: DTN (Reservoir, Blood, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K932252 (1993). 7 ancestors in all.
3 later devices descend from it; 1 cites it directly.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982136: Jostra Venous Hardshell Cardiotomic Reservoir VHK 4200, Schiff & Co. (1999) Summary page 1.
- K003551: Venous Hardshell Cardiotomy Resevoir, Model VHK 4201, Jostra AG (2001) Summary page 1.
- K061072: Rotaflow Centrifugal Pump with Safeline Coating, Model BSQ-RF-32, Maquet Cardiopulmonary, AG (2006) Summary page 1.

## Most influential descendants
- K090534: Venous Hardshell Cardiotomy Reserviors (2009), 2 descendants of its own
- K102919: Neonatal Venous Hardshell Cardiotomy Reservoir, Pediatric Venous Hardshell Carsiotomy Reservoir, Neonatal Venous Hardshe (2011), 1 descendant of its own
- K141432: Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy Reservior, Neonatal Venous Hardhsh (2014), 0 descendants of its own

## Indications for use
The Jostra Venous Hardshell Cardiotomy Reservoir (non-vacuum-tight model) is designed to collect, store and filter the blood in an extracorporeal circuit during cardiopulmonary bypass procedures up to six hours in adult surgery. It can be integrated into almost all perfusion systems. The Jostra Venous Hardshell Cardiotomy Reservoir is designed and sold for use only as indicated. The Jostra Venous Hardshell Cardiotomy Reservoir (vacuum-tight model) is designed to collect, store and filter the blood in an extracorporeal circuit during cardiopulmonary bypass procedures with or without vacuum assisted venous return up to six hours in adult surgery. It can be integrated into almost all perfusion systems. The Jostra Venous Hardshell Cardiotomy Reservoir is designed and sold for use only as indicated. This reservoir is also designed to be used postoperatively as a drainage and autotransfusion reservoir (e.g. for chest drainage) to return autologous blood shed from the chest to the patient for volume replacement.

Source page: https://510kreport.com/device/K061743
Methodology: https://510kreport.com/methodology