# K980732: 3M Cdi Quick-Cells with Heparin Treatment

- Pathway: 510(k) (Traditional)
- Applicant: 3M Healthcare
- Decided: May 15, 1998 after 79 days
- Product code: DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4330
- 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 K890113 (1989). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K890113: The Cdi (R) System 400, Cardiovascular Devices, Inc. (1989) Summary page 1.
- K902654: Cdi (TM) System 100 Monitoring System, 3M Health Care, Ltd. (1990) Summary page 1.

## Most influential descendants
- K140042: 1.5MM Hydro Expandable Lemaitre Valvulotome (2014), 0 descendants of its own

## Indications for use
These cells are to be used with the CDI System 400 Extracorporeal Blood Gas Monitoring System, which is intended for use during cardiopulmonary bypass procedures when contiuous monitoring of blood gases is desired.

Source page: https://510kreport.com/device/K980732
Methodology: https://510kreport.com/methodology