# K872719: Expanded Use of Hardshell Venous Reserv. W/Filter

- Pathway: 510(k) (Traditional)
- Applicant: Shiley, Inc.
- Decided: Sep 30, 1987 after 82 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K964908: VRF40 Venous Reservoir with Integral Cardiotomy Filter (1997), 0 descendants of its own
- K964907: Venomidicard Pediatric Venous Reservoir with Integralcardiotomy Filter/Midicard Pediatric Cardiotomy Reservoir with Filt (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K872719
Methodology: https://510kreport.com/methodology