# K982840: BSC Sonicath Ultra Intravascular Ultrasound Imaging Wire with Detachable Adapter & BSC Sonicath Ultra Ultrasound Imaging

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Nov 9, 1998 after 89 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- 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 K942927 (1995). 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)
- 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.
- K942927: 0.035 in. Wise Wire, Boston Scientific Corp (1995) Summary page 1.

## Indications for use
The BSC Imaging Wire is intended to be used for the ultrasound examination of peripheral intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. The Imaging Wire is specifically indicated for use with diagnostic or interventional devices which are compatible with 0.035” guidewires.

Source page: https://510kreport.com/device/K982840
Methodology: https://510kreport.com/methodology