# K993818: Antegrade/Retrograde Perfusion Adapter with or Without Pressure Line

- Pathway: 510(k) (Traditional)
- Applicant: California Medical Laboratories, Inc.
- Decided: Feb 8, 2000 after 90 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: none
- 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. The FDA summary names its predicate without a number.
- (no number) Baxter Research Medical, Inc. Cardioplegia Antegrade-Retrograde Solution Infusion with or without Retrograde Pressure Monitoring: named in the summary without a submission number

## Indications for use
The Antegrade/Retrograde Perfusion Adapter is indicated for use to deliver cardioplegia solution to either the aortic root or coronary sinus. The Antegrade/Retrograde Perfusion Adapter with Pressure Line is indicated for use to deliver cardioplegia solution to either the aortic root or coronary sinus while continually monitoring the pressure of the coronary sinus.

Source page: https://510kreport.com/device/K993818
Methodology: https://510kreport.com/methodology