# K960310: Epic Introducer Sheath

- Pathway: 510(k) (Traditional)
- Applicant: North American Instrument Corp.
- Decided: Feb 7, 1996 after 16 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
No predicates in its family tree.
2 later devices descend 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K980504: Emcee Introducer Sheath, Dilator, Obturator, Introducer Set (1998), 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

Source page: https://510kreport.com/device/K960310
Methodology: https://510kreport.com/methodology