# K980504: Emcee Introducer Sheath, Dilator, Obturator, Introducer Set

- Pathway: 510(k) (Traditional)
- Applicant: Schneider/Namic
- Decided: Aug 7, 1998 after 179 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: 2 generations back to K810675 (1981). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915078: Morse Hemostatic Catheter Introducer Set, North American Instrument Corp. (1992) Summary page 1.
- K960310: Epic Introducer Sheath, North American Instrument Corp. (1996) Summary page 1.
- K895044: Dual Guide Introducer Catheter, Cook, Inc. (1990) Summary page 1.
- K810675: Arrow Radial Artery Catheterization Set, Arrow Intl., Inc. (1981) Summary page 1.
- K962746: Cordis Avanti Trans-Radial Catheter Sheath Introducer Kit, Cordis Corp. (1996) Summary page 1.

## 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
Intended for use in facilitating the percutaneous introduction of catheters, interventional devices, and temporary pacing leads into the vasculature (including the radial artery).

Source page: https://510kreport.com/device/K980504
Methodology: https://510kreport.com/methodology