# K040552: Model 3100 Series Sheath Introducer Kits, Models 3110, 3130

- Pathway: 510(k) (Traditional)
- Applicant: Cryocor, Inc.
- Decided: May 28, 2004 after 87 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: 1 generation back to K964518 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973840: Fast-Cath (TM) Intra-Cardiac Introducer, Daig Corp. (1998) Summary page 2.
- K964518: Fast-Cath Transseptal Catheter Introducer, Daig Corp. (1997) Summary page 2.

## Indications for use
The CryoCor Model 3100 Series Sheath Kits are intended to facilitate the percutaneous introduction of cardiovascular catheters into the heart, while preventing backflow of blood.

Source page: https://510kreport.com/device/K040552
Methodology: https://510kreport.com/methodology