# K090878: Modification to Terumo's Tenderflow Pediatric Venous Return Cannulae (X-Coating)

- Pathway: 510(k) (Special)
- Applicant: Terumo Cardiovascular Systems Corp.
- Decided: Apr 3, 2009 after 3 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) TenderFlow™ Pediatric Venous Return Cannula: named in the summary without a submission number

## Recalls of this device
- May 23, 2014 · Class II · Z-2103-2014: During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications

## Indications for use
The X-coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. The X-coated TenderFlow™ Pediatric Venous Return Cannula is indicated for use in dual cannulation of the superior and inferior vena cava and single cannulation of the right atrium during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.

Source page: https://510kreport.com/device/K090878
Methodology: https://510kreport.com/methodology