# K983039: Emcee Infusion Introducer Sheath, Emcee Infusion Introducer Set Dilator, Emcee Infusion Introducer Sheath Set, Emcee Inf

- Pathway: 510(k) (Traditional)
- Applicant: Schneider/Namic
- Decided: May 7, 1999 after 249 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K810675 (1981). 11 ancestors in all.
No later device cites it as a predicate yet.
1 of 12 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980504: Emcee Introducer Sheath, Dilator, Obturator, Introducer Set, Schneider/Namic (1998) Summary page 1.
- K952317: Kaplan-Simpson InfusaSleeve II Catheter, Localmed, Inc. (1995) Summary page 1.

## Indications for use
Intended for use in facilitating the percutaneous introduction of catheters, interventional devices. and temporary pacing leads into the vasculature. The device also will deliver therapeutic solutions administered through the stopcock sidearm to the vasculature wall surrounding the sheath,

Source page: https://510kreport.com/device/K983039
Methodology: https://510kreport.com/methodology