# K022860: Atlantis PV Imaging Catheter, Model 36456

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific, Target
- Decided: Nov 21, 2002 after 85 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K890772 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K890772: Ultrasonic Imaging Catheter for Cardiac Appli., Boston Scientific Corp (1989) Summary page 1.
- K970049: BSC, Sonicath Ultra Imaging Catheter 3.2F/20MHZ (37410/456221 & BSC, Sonicath Ultra Imaging Catheter 2.9F/20MHZ/37411/, Cardiovascular Imaging Systems, Inc. (1997) Summary page 1.

## Indications for use
The AtlantisTMPV 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/K022860
Methodology: https://510kreport.com/methodology