# K952317: Kaplan-Simpson InfusaSleeve II Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Localmed, Inc.
- Decided: Jun 28, 1995 after 42 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
Longest line of descent: 1 generation back to K950615 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950615: Kaplan-Simpson Infusasleeve Catheter, Localmed, Inc. (1995) Summary page 4.

## Most influential descendants
- K983039: Emcee Infusion Introducer Sheath, Emcee Infusion Introducer Set Dilator, Emcee Infusion Introducer Sheath Set, Emcee Inf (1999), 0 descendants of its own

## Indications for use
The Kaplan-Simpson 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/K952317
Methodology: https://510kreport.com/methodology