# K002973: Embol-X Introducer, Model CF00200

- Pathway: 510(k) (Traditional)
- Applicant: Embol-X, Inc.
- Decided: Apr 26, 2001 after 216 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
- K123714: Edwards Embol-X Introducer Sheath (2013), 1 descendant of its own
- K140398: Embol-X Introducer Sheath (2014), 0 descendants of its own

Source page: https://510kreport.com/device/K002973
Methodology: https://510kreport.com/methodology