# K964973: Gish Cap VRF45 Cardiotomy/Venous Reservoir

- Pathway: 510(k) (Traditional)
- Applicant: Gish Biomedical, Inc.
- Decided: Mar 10, 1997 after 88 days
- Product code: DTN (Reservoir, Blood, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K883923 (1988). 3 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K890504: Cardiotomy/Autotransfusion/Pleural Drainage Venous, Gish Biomedical, Inc. (1989) Summary page 1.
- K883923: Cardiotomy/Venous Reservoir NO.: CVR Series, Gish Biomedical, Inc. (1988) Summary page 1.
- K922799: Capiox SX Hollow Fiber Oxygenator, Terumo Medical Corp. (1993) Summary page 1.

## Most influential descendants
- K030726: Gish CAPVRF44 Hardshell Venous Reservoir with GBS Coating (2003), 1 descendant of its own
- K083131: Medos Hilite Reservoir, Model: 4030 (2009), 0 descendants of its own
- K081947: Gish CAPVRF44 Hardshell Venous Reservoir with HA Coating (2009), 0 descendants of its own

## Indications for use
The Gish CAP VRF45 is indicated for use during cardiopulmonary bypass surgery as a storage reservoir for venous return blood and to filter and defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit. The CAP VRF4S is indicated for the collection and autotransfusion of the same patient’s postoperative shed blood.

Source page: https://510kreport.com/device/K964973
Methodology: https://510kreport.com/methodology