# K050577: Atlantis SR PRO2 Coronary Imaging Catheter, Model 39014

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Mar 30, 2005 after 23 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
17 later devices descend from it; 4 cite it directly.
0 of 18 devices 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) BSS Atlantis SR Plus Coronary Imaging Catheter: named in the summary without a submission number

## Most influential descendants
- K063312: Modification to Atlantis SR Pro 2 and SR Pro Coronary Imaging Catheters, Model 39014 and 38942 (2006), 13 descendants of its own
- K111043: Atlantis SR PRO2 Coronary Imaging Catheter, Icross Coronary Imaging Catheter (2011), 9 descendants of its own
- K123621: Opticross 40 MHZ Coronary Imaging Catheter (2013), 8 descendants of its own
- K153617: OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution) (2016), 5 descendants of its own
- K173820: OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (e-DFU) (2018), 3 descendants of its own

## Recalls of this device
- Mar 28, 2011 · Not classified · Z-2418-2011: Catheter tip detachment that is not associated with elongation of the catheter typically caused by excessive pulling forces. EXPANDED: Boston Scientific is initiating a recall of all iCross Coronary I
- Mar 28, 2011 · Not classified · Z-2419-2011: Catheter tip detachment that is not associated with elongation of the catheter typically caused by excessive pulling forces. EXPANDED: Boston Scientific is initiating a recall of all iCross Coronary I

## Indications for use
The Atlantis SR Pro2 catheter is intended for ultrasound examination of coronary intravascular pathology ONLY. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

Source page: https://510kreport.com/device/K050577
Methodology: https://510kreport.com/methodology