# K063312: Modification to Atlantis SR Pro 2 and SR Pro Coronary Imaging Catheters, Model 39014 and 38942

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Nov 30, 2006 after 28 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
Longest line of descent: 1 generation back to K050577 (2005). 1 ancestor in all.
13 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050577: Atlantis SR PRO2 Coronary Imaging Catheter, Model 39014, Boston Scientific Corp (2005) Summary page 1.

## Most influential descendants
- 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
- K173284: OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU) (2017), 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 TM SR Pro 2 Coronary Imaging 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/K063312
Methodology: https://510kreport.com/methodology