# K170583: Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Mar 17, 2017 after 17 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 K926226 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926226: Intersept Filtered Cardiotomy Reservoir, Medtronic Vascular (1993) Summary page 5.
- K151110: Intersept Filtered Cardiotomy Reservoir, Medtronic, Inc. (2015) Summary page 6.

## Indications for use
The Intersept filtered cardiotomy reservoir with Cortiva bioactive surface is indicated for use in the cardiopulmonary bypass circuit during surgery for: • an air/fluid separation chamber • a temporary storage reservoir for priming solution and blood • the filtration of particulates from bank blood and the storage and filtration of blood recovered from the field by suction • the addition of medications or other fluids.

Source page: https://510kreport.com/device/K170583
Methodology: https://510kreport.com/methodology