# K152403: Permanent Sled Bag

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific
- Decided: Sep 22, 2015 after 28 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: 6 generations back to K921750 (1992). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130243: Ilab Ultrasound Imaging System, Boston Scientific Corp (2013) Summary page 4.

## Indications for use
The sterile bag is intended to cover the motordrive/sled assembly during intravascular ultrasound procedures to maintain the sterile field and prevent transfer of microorganisms, body fluids and particulate material to the patient and healthcare worker.

Source page: https://510kreport.com/device/K152403
Methodology: https://510kreport.com/methodology