# K033714: MVR 1200 PC: Sorin Monolyth Venous Reservoir 1200 PC with Phosphorylcholine Coating

- Pathway: 510(k) (Special)
- Applicant: Dideco S.P.A.
- Decided: Dec 11, 2003 after 15 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: 5 generations back to K922933 (1992). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933481: Sorin Monolyth Venous Reservoir, Sorin Biomedical, Inc. (1993) Summary page 1.
- K022450: Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial Filter and Hardhshell Venous/Cardiotomy, Dideco S.P.A. (2002) Summary page 1.
- K031223: Synthesis Mimesys Adult Membrane Oxygenator, Dideco S.P.A. (2003) Summary page 1.

## Indications for use
The MVR 1200 PC is intended for use as a storage reservoir for blood in an extracorporeal bypass circuit for periods up to six hours.

Source page: https://510kreport.com/device/K033714
Methodology: https://510kreport.com/methodology