# K151110: Intersept Filtered Cardiotomy Reservoir

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: May 27, 2015 after 30 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Intersept® Cardiotomy Reservoir with Filter: named in the summary without a submission number

## Most influential descendants
- K170583: Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface (2017), 0 descendants of its own

## Indications for use
The Intersept filtered cardiotomy reservoir 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. The Intersept filtered cardiotomy reservoir is also indicated for use after open heart surgery for: • the post-operative collection of autologous blood from the chest and the aseptic return of blood to the patient for volume replacement.

Source page: https://510kreport.com/device/K151110
Methodology: https://510kreport.com/methodology