# K845045: Venous Return  Catheter SS-1

- Pathway: 510(k) (Traditional)
- Applicant: Dlp, Inc.
- Decided: Apr 3, 1985 after 96 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
No predicates in its family tree.
18 later devices descend from it; 4 cite it directly.
2 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K031827: Ultraflex Venous Cannula, Model 970XX and CB970XX (2003), 15 descendants of its own
- K052081: Remote Access Perfusion (Rap) Femoral Venous Cannula (2005), 8 descendants of its own
- K022272: Malleable Single Stage Venous Cannula, Models 68112-68140 (15 Total Codes) (2003), 7 descendants of its own
- K060101: Estech Aortic Easy Flow Cannula (2006), 6 descendants of its own
- K033264: Malleable Single Stage Venous Cannula with Carmeda Bioactive Surface, Model CB681XX Series (2003), 6 descendants of its own

## Recalls of this device
- Dec 14, 2011 · Not classified · Z-0808-2012: Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a co
- Dec 14, 2011 · Not classified · Z-0812-2012: Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a co
- Sep 15, 2004 · Not classified · Z-1489-04: Spiral tip from DLP VAD cannula may be loose and potentially detach during use.

Source page: https://510kreport.com/device/K845045
Methodology: https://510kreport.com/methodology