# K050684: Atlantis PV

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: May 20, 2005 after 64 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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.

## Most influential descendants
- K080272: Atlantis Pvimaging Catheter, Model H749364560 (2008), 1 descendant of its own
- K200733: Opticross 35 15 MHz Peripheral Imaging Catheter (2020), 0 descendants of its own

## Indications for use
The AtlantisTM PV Imaging Catheter is intended for ultrasound examination of peripheral pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

Source page: https://510kreport.com/device/K050684
Methodology: https://510kreport.com/methodology
