# K963756: Ibc Cardiac Suction Ward

- Pathway: 510(k) (Traditional)
- Applicant: International Biophysics Corp.
- Decided: Nov 14, 1997 after 423 days
- Product code: DTS (Sucker, Cardiotomy Return, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4420
- Recalls of this device: 2 (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) Research Medical Intracardiac Sucker: named in the summary without a submission number

## Most influential descendants
- K053021: Estech Clearview MV Atrial Depressor (2006), 0 descendants of its own

## Recalls of this device
- Aug 7, 2015 · Class II · Z-2422-2015: It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.
- Oct 5, 2011 · Not classified · Z-0273-2012: Potential for the sterility to be compromised.

## Indications for use
The IBC Cardiac Suction Wand is intended for use by a Cardiac Surgeon during open heart surgery for the collection of blood and other fluids from the sterile surgical field for filtering and return to the patient via the Cardiotomy line. It is also intended for use by surgeons for the removal of waste fluids from the surgical field.

Source page: https://510kreport.com/device/K963756
Methodology: https://510kreport.com/methodology