# K900994: Antegrade/Retrograde Y W/Integral Selector Swit.

- Pathway: 510(k) (Traditional)
- Applicant: Dlp, Inc.
- Decided: Aug 15, 1990 after 166 days
- Product code: DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4290
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Jun 22, 2017 · Class II · Z-2765-2017: Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.

Source page: https://510kreport.com/device/K900994
Methodology: https://510kreport.com/methodology