# K040776: Atlantis SR, Model C4020; Atlantis SR Plus, Model 35975

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Apr 29, 2004 after 34 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Atlantis TM SR and Atlantis TM SR PLUS Imaging Catheters are intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound is indicated in patients who are candidates for transluminal coronary interventional procedures.

Source page: https://510kreport.com/device/K040776
Methodology: https://510kreport.com/methodology