# K070605: Jostra Venous Softbag Reservoirs with and Without Safeline Coating

- Pathway: 510(k) (Traditional)
- Applicant: Maquet Cardiopulmonary, AG
- Decided: Jan 4, 2008 after 305 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). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050111: Smarxt BMR 1900 Closed Venous Reservoir Bag, Cobe Cardiovascular, Inc. (2005)
- K920774: MVR Collapsible Venous Reservoir Bag, Medtronic Vascular (1992) Summary page 1.
- K061072: Rotaflow Centrifugal Pump with Safeline Coating, Model BSQ-RF-32, Maquet Cardiopulmonary, AG (2006) Summary page 1.

## Most influential descendants
- K090690: Venous Softbag Reservoirs with Softline Coating (2009), 0 descendants of its own

## Indications for use
The Jostra Venous Softbag Reservoirs are indicated for use in extracorporeal circuits during cardiopulmonary bypass procedures in the field of open-heart-surgery. The utilization period of this device is restricted to six hours. Blood contact longer than 6 hours is not recommended. Application and use of the softbag reservoir is in the sole responsibility of the respective physician.

Source page: https://510kreport.com/device/K070605
Methodology: https://510kreport.com/methodology