# K860149: Venous Perfusion Cannula W/Cuff Cat. NO. 94015

- Pathway: 510(k) (Traditional)
- Applicant: Dlp, Inc.
- Decided: Mar 31, 1986 after 75 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 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
- K030696: Retrograde Coronary Sinus Perfusion Cannula with NO Pressure Line (15 French, Manual and Auto Inflate) (2003), 2 descendants of its own
- K253203: Retrograde Coronary Sinus Perfusion Cannulae (2026), 0 descendants of its own
- K132995: DLP Retrograde Coronary Sinus Perfusion Cannula Without Pressure Monitoring Line, DLP Retrograde Coronary Sinus Perfusio (2013), 0 descendants of its own
- K123762: DLP Retrograde Coronary Sinus Perfusion Cannula with Auto-Inflate Cuff (2013), 0 descendants of its own
- K090869: Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate Cannula, Model 94113TD (2009), 0 descendants of its own

## Recalls of this device
- Apr 21, 2026 · Class II · Z-2217-2026: Certain lots of product have the potential for a sterile barrier breach.
- Apr 21, 2026 · Class II · Z-2214-2026: Certain lots of product have the potential for a sterile barrier breach.
- Apr 21, 2026 · Class II · Z-2216-2026: Certain lots of product have the potential for a sterile barrier breach.
- Apr 21, 2026 · Class II · Z-2220-2026: Certain lots of product have the potential for a sterile barrier breach.
- Apr 21, 2026 · Class II · Z-2219-2026: Certain lots of product have the potential for a sterile barrier breach.
- Apr 21, 2026 · Class II · Z-2222-2026: Certain lots of product have the potential for a sterile barrier breach.
- Apr 21, 2026 · Class II · Z-2218-2026: Certain lots of product have the potential for a sterile barrier breach.
- Apr 21, 2026 · Class II · Z-2221-2026: Certain lots of product have the potential for a sterile barrier breach.
- Apr 21, 2026 · Class II · Z-2215-2026: Certain lots of product have the potential for a sterile barrier breach.

Source page: https://510kreport.com/device/K860149
Methodology: https://510kreport.com/methodology