# K953945: Retrograde Coronary Sinus Perfusion Cannula with Elongated & Treaded Cuff & Introducer Stylet

- Pathway: 510(k) (Traditional)
- Applicant: Dlp, Inc.
- Decided: Mar 26, 1996 after 218 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) DLP marketed RCSP cannula: named in the summary without a submission number
- (no number) Research Medical marketed RCSP cannula: named in the summary without a submission number
- (no number) Sarns 3M marketed RCSP cannula: named in the summary without a submission number

## Most influential descendants
- K253203: Retrograde Coronary Sinus Perfusion Cannulae (2026), 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.

## Indications for use
The indications or intended use for the DLP Elongated and Treaded Cuff Retrograde Coronary Sinus Perfusion (RCSP) cannula are the same as the DLP, Research Medical and Sarns 3M marketed RCSP cannula. The cannula are intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus.

Source page: https://510kreport.com/device/K953945
Methodology: https://510kreport.com/methodology