# K051601: Pinnacle Destination Peripheral Guiding Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: Aug 4, 2005 after 49 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: 2 generations back to K924607 (1993). 2 ancestors in all.
60 later devices descend from it; 4 cite it directly.
2 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012812: Carotid Guiding Sheath, Terumo Medical Corp. (2001) Summary page 2.

## Most influential descendants
- K080415: Device Modification to Pinnacle Destination Peripheral Guiding Sheath (2008), 44 descendants of its own
- 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
- K081341: Reinforced Catheter Introducer System (Rcis) (2008), 13 descendants of its own
- K111004: Hansen Medical Vascular Catheter Control System and Catheter (2012), 10 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/K051601
Methodology: https://510kreport.com/methodology