# K081341: Reinforced Catheter Introducer System (Rcis)

- Pathway: 510(k) (Traditional)
- Applicant: Thomas Medical Products, Inc.
- Decided: May 14, 2008 after 1 day
- 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 K924607 (1993). 4 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970229: Arrow Transseptal Super Arrow-Flex Percutaneous Set, Arrow Intl., Inc. (1998) Summary page 1.
- K051601: Pinnacle Destination Peripheral Guiding Sheath, Terumo Medical Corp. (2005)

## Most influential descendants
- K101497: Delivery Sheath, Model Adelante Breezeway (2010), 8 descendants of its own
- K120459: Steerable Guiding Sheath, Model Adelante Destino (2012), 7 descendants of its own
- K151951: Destino Reach (2015), 6 descendants of its own
- K240829: AuST Steerable Sheath (2024), 5 descendants of its own
- K242106: AuST Steerable Sheath (2024), 4 descendants of its own

## Indications for use
The [Reinforced Catheter Introducer System]* is indicated for use in arterial and venous procedures requiring percutaneous introduction of therapeutic or diagnostic intravascular devices.

Source page: https://510kreport.com/device/K081341
Methodology: https://510kreport.com/methodology