# K080272: Atlantis Pvimaging Catheter, Model H749364560

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Mar 11, 2008 after 39 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- 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 K050684 (2005). 1 ancestor in all.
1 later device descends 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)
- K050684: Atlantis PV, Boston Scientific Corp (2005) Summary page 1.

## Most influential descendants
- K200733: Opticross 35 15 MHz Peripheral Imaging Catheter (2020), 0 descendants of its own

## Recalls of this device
- Jan 6, 2014 · Class II · Z-0900-2014: Reports of physicians experiencing inability to pass a 0.035" guidewire through the guidewire lumen and exit port at the (proximal) Y-manifold of the imaging catheter.
- Oct 9, 2008 · Not classified · Z-0837-2009: Product is mislabeled as having a shelf life of 3 years, where the actual shelf life is 1 year.

## 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/K080272
Methodology: https://510kreport.com/methodology