# K080415: Device Modification to Pinnacle Destination Peripheral Guiding Sheath

- Pathway: 510(k) (Special)
- Applicant: Terumo Medical Corp.
- Decided: Mar 7, 2008 after 22 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: 3 generations back to K924607 (1993). 3 ancestors in all.
44 later devices descend from it; 4 cite it directly.
2 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051601: Pinnacle Destination Peripheral Guiding Sheath, Terumo Medical Corp. (2005) Summary page 3.

## Most influential descendants
- K091329: Pinnacle Destination Peripheral Guiding Sheath (2009), 30 descendants of its own
- K142829: Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification; Flexor Check-Flo Introducers, Ansel Modification with High-Flex Dilator and Hydrophilic Coating; Flexor Check-Flo Introducer Balkin Up and Over Contralateral Design; Flexor Up and Over Balkin Contralateral Introducer; Flexor Check-Flo Introducer, Raabe Modification; Flexor Check-Flo Performer Introducer (2015), 13 descendants of its own
- K111004: Hansen Medical Vascular Catheter Control System and Catheter (2012), 10 descendants of its own
- K100799: Fortress Introducer Sheath System Model 358813, 358814, 358815 (2011), 10 descendants of its own
- K132369: Magellan Robotic System, Magellan Robotic Catheter 9FR (2013), 9 descendants of its own

## Indications for use
The Pinnacle® Destination® Peripheral Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to lower extremity access via a contralateral approach.

Source page: https://510kreport.com/device/K080415
Methodology: https://510kreport.com/methodology