# K063618: Tenderflow Periatric Arterial Cannula

- Pathway: 510(k) (Special)
- Applicant: Terumo Cardiovascular Systems Corp.
- Decided: Mar 13, 2007 after 98 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 24 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K930620 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930620: Bard (R) William Harvey (R) Arterial Straigh Cannula, C.R. Bard, Inc. (1993) Summary page 1.

## Recalls of this device
- Oct 16, 2008 · Not classified · Z-0637-2009: The introducer or stylet is difficult to remove from the pediatric arterial cannula body, which may result in the need to remove the cannula and replace it.
- Oct 16, 2008 · Not classified · Z-0638-2009: The introducer or stylet is difficult to remove from the pediatric arterial cannula body, which may result in the need to remove the cannula and replace it.
- Oct 16, 2008 · Not classified · Z-0639-2009: The introducer or stylet is difficult to remove from the pediatric arterial cannula body, which may result in the need to remove the cannula and replace it.
- Oct 16, 2008 · Not classified · Z-0640-2009: The introducer or stylet is difficult to remove from the pediatric arterial cannula body, which may result in the need to remove the cannula and replace it.
- Oct 16, 2008 · Not classified · Z-0630-2009: The introducer or stylet is difficult to remove from the pediatric arterial cannula body, which may result in the need to remove the cannula and replace it.
- Oct 16, 2008 · Not classified · Z-0633-2009: The introducer or stylet is difficult to remove from the pediatric arterial cannula body, which may result in the need to remove the cannula and replace it.
- Oct 16, 2008 · Not classified · Z-0634-2009: The introducer or stylet is difficult to remove from the pediatric arterial cannula body, which may result in the need to remove the cannula and replace it.
- Oct 16, 2008 · Not classified · Z-0636-2009: The introducer or stylet is difficult to remove from the pediatric arterial cannula body, which may result in the need to remove the cannula and replace it.
- Oct 16, 2008 · Not classified · Z-0641-2009: The introducer or stylet is difficult to remove from the pediatric arterial cannula body, which may result in the need to remove the cannula and replace it.
- Oct 16, 2008 · Not classified · Z-0631-2009: The introducer or stylet is difficult to remove from the pediatric arterial cannula body, which may result in the need to remove the cannula and replace it.
- Oct 16, 2008 · Not classified · Z-0632-2009: The introducer or stylet is difficult to remove from the pediatric arterial cannula body, which may result in the need to remove the cannula and replace it.
- Oct 16, 2008 · Not classified · Z-0635-2009: The introducer or stylet is difficult to remove from the pediatric arterial cannula body, which may result in the need to remove the cannula and replace it.
- May 22, 2007 · Not classified · Z-0877-2007: The bond may fail and a leak or separation of the device occur at the distal end (where this device connects to the arterial line).
- May 22, 2007 · Not classified · Z-0881-2007: The bond may fail and a leak or separation of the device occur at the distal end (where this device connects to the arterial line).
- May 22, 2007 · Not classified · Z-0879-2007: The bond may fail and a leak or separation of the device occur at the distal end (where this device connects to the arterial line).
- May 22, 2007 · Not classified · Z-0880-2007: The bond may fail and a leak or separation of the device occur at the distal end (where this device connects to the arterial line).
- May 22, 2007 · Not classified · Z-0883-2007: The bond may fail and a leak or separation of the device occur at the distal end (where this device connects to the arterial line).
- May 22, 2007 · Not classified · Z-0885-2007: The bond may fail and a leak or separation of the device occur at the distal end (where this device connects to the arterial line).
- May 22, 2007 · Not classified · Z-0874-2007: The bond may fail and a leak or separation of the device occur at the distal end (where this device connects to the arterial line).
- May 22, 2007 · Not classified · Z-0876-2007: The bond may fail and a leak or separation of the device occur at the distal end (where this device connects to the arterial line).
- May 22, 2007 · Not classified · Z-0878-2007: The bond may fail and a leak or separation of the device occur at the distal end (where this device connects to the arterial line).
- May 22, 2007 · Not classified · Z-0884-2007: The bond may fail and a leak or separation of the device occur at the distal end (where this device connects to the arterial line).
- May 22, 2007 · Not classified · Z-0875-2007: The bond may fail and a leak or separation of the device occur at the distal end (where this device connects to the arterial line).
- May 22, 2007 · Not classified · Z-0882-2007: The bond may fail and a leak or separation of the device occur at the distal end (where this device connects to the arterial line).

## Indications for use
The TenderFlowTM Pediatric Arterial Cannula is a surgically invasive device intended for short term use and indicated for cannulation and perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.

Source page: https://510kreport.com/device/K063618
Methodology: https://510kreport.com/methodology