# K200410: Reconnaissance PV .018 OTW Digital IVUS Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Philips Image Guided Therapy Corporation
- Decided: May 22, 2020 after 93 days
- Product code: OBJ (Catheter, Ultrasound, Intravascular)
- 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
Longest line of descent: 9 generations back to K934139 (1995). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150442: Volcano Visions PV .018 Digital IVUS Catheter, Volcano Corporation (2015) Summary page 4.
- K143701: Eagle Eye Platinum Catheter, Eagle Eye Platinum Short Tip Catheter, Visions PV .014 Platinum, Volcano Corporation (2015) Summary page 4.

## Most influential descendants
- K233948: Provisio™ SLT IVUS™ System (2024), 0 descendants of its own

## Indications for use
The Reconnaissance PV .018 Digital IVUS catheter is designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicted for use in cerebral vessels. The Reconnaissance PV .018 Digital IVUS catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

Source page: https://510kreport.com/device/K200410
Methodology: https://510kreport.com/methodology