# K964907: Venomidicard Pediatric Venous Reservoir with Integralcardiotomy Filter/Midicard Pediatric Cardiotomy Reservoir with Filt

- Pathway: 510(k) (Traditional)
- Applicant: Sorin Biomedical, Inc.
- Decided: Aug 21, 1997 after 255 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 K872719 (1987). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K872719: Expanded Use of Hardshell Venous Reserv. W/Filter, Shiley, Inc. (1987) Summary page 2.

## Indications for use
The Dideco Venomidicard and Midicard are hardshell blood collection reservoirs intended for use in CPB circuits and postoperative blood salvage procedures.

Source page: https://510kreport.com/device/K964907
Methodology: https://510kreport.com/methodology