# K980957: Kaplan-Simpson Infusasleeve II

- Pathway: 510(k) (Traditional)
- Applicant: Localmed, Inc.
- Decided: Jun 10, 1998 after 86 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 IIa: named in the summary without a submission number
- (no number) InfusaSleeve I1: named in the summary without a submission number

## Indications for use
The InfusaSleeve II 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/K980957
Methodology: https://510kreport.com/methodology