# K950615: Kaplan-Simpson Infusasleeve Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Localmed, Inc.
- Decided: Apr 19, 1995 after 68 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K952317: Kaplan-Simpson InfusaSleeve II Catheter (1995), 1 descendant of its own
- K983039: Emcee Infusion Introducer Sheath, Emcee Infusion Introducer Set Dilator, Emcee Infusion Introducer Sheath Set, Emcee Inf (1999), 0 descendants of its own
- K961294: Scimed Dispatch Gold Coronary Catheter (1996), 0 descendants of its own

## Indications for use
The InfusaSleeve is intended to infuse fluids such as heparanized saline, diagnostic agents such as contrast media, and thrombolytic agents such as urokinase into the coronary vasculature.

Source page: https://510kreport.com/device/K950615
Methodology: https://510kreport.com/methodology