# K972175: Infusasleeve Iia (IS-2A)

- Pathway: 510(k) (Traditional)
- Applicant: Localmed, Inc.
- Decided: Aug 28, 1997 after 80 days
- Product code: QEY (Mechanical Thrombolysis Catheter)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) InfusaSleeve™ II: named in the summary without a submission number

## Indications for use
The InfusaSleeve Ila is intended to infuse fluids such as heparinized saline, diagnostic agents such as contrast media, and thrombolytic agents such as urokinase into the coronary vasculature. The catheter is designed for use with a commercially available dilatation catheter to facilitate selective and subselective access and regional infusion.

Source page: https://510kreport.com/device/K972175
Methodology: https://510kreport.com/methodology