# K914299: Cardiac Catherization Kit

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jun 3, 1992 after 252 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Sep 28, 2012 · Class II · Z-0055-2013: ICU Medical, Inc. has identified a potential comingling of components where a 60 drop micro drip chamber may have been included on a 20 drop macro drip set.

Source page: https://510kreport.com/device/K914299
Methodology: https://510kreport.com/methodology