# K043453: Sterilemed Reprocessed Ivus Imaging Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Mar 1, 2005 after 76 days
- Product code: OWQ (Reprocessed Intravascular Ultrasound Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K921148 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992631: Acunav Diagnostic Ultrasound Catheter, Acuson Corp. (1999) Summary page 1.

## Recalls of this device
- Oct 8, 2025 · Class II · Z-0574-2026: Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as infection, vascula
- Oct 8, 2025 · Class II · Z-0573-2026: Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as infection, vascula
- Aug 8, 2008 · Not classified · Z-0551-2009: SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of th

## Indications for use
The SterilMed Reprocessed Imaging Catheter is intended for intravascular or intracardiac ultrasound imaging in order to provide visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart. This device is intended for use in the right-heart only.

Source page: https://510kreport.com/device/K043453
Methodology: https://510kreport.com/methodology