# K081947: Gish CAPVRF44 Hardshell Venous Reservoir with HA Coating

- Pathway: 510(k) (Traditional)
- Applicant: Gish Biomedical, Inc.
- Decided: Feb 4, 2009 after 211 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: 3 generations back to K883923 (1988). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964973: Gish Cap VRF45 Cardiotomy/Venous Reservoir, Gish Biomedical, Inc. (1997) Summary page 1.
- K030726: Gish CAPVRF44 Hardshell Venous Reservoir with GBS Coating, Gish Biomedical, Inc. (2003) Summary page 1.

## Indications for use
The Gish CAPVRF44 Hardshell Venous Reservoirs are indicated for use during cardiopulmonary bypass surgery as a storage reservoir for gravity and augmented venous return blood and to filter and defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit at flow rates of one (1.0) to eight (8.0) liters per minute for periods up to six hours (6.0) hours. The Gish CAPVRF44 Hardshell Venous Reservoirs are also indicated for the collection and autotransfusion of the same patients post operative shed blood with the addition of the Postoperative Conversion Pack with water seal/manometer.

Source page: https://510kreport.com/device/K081947
Methodology: https://510kreport.com/methodology