# K883923: Cardiotomy/Venous Reservoir NO.: CVR Series

- Pathway: 510(k) (Traditional)
- Applicant: Gish Biomedical, Inc.
- Decided: Nov 4, 1988 after 49 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K964973: Gish Cap VRF45 Cardiotomy/Venous Reservoir (1997), 3 descendants of its own
- 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
- K022281: Safe Maxi Venous/Cardiotomy Reservior, Model 016045 (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K883923
Methodology: https://510kreport.com/methodology