# K081046: Pinnacle Destination Peripheral Guiding Sheath

- Pathway: 510(k) (Special)
- Applicant: Terumo Medical Corp.
- Decided: May 21, 2008 after 37 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: 4 generations back to K924607 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080415: Device Modification to Pinnacle Destination Peripheral Guiding Sheath, Terumo Medical Corp. (2008) Summary page 1.

## 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/K081046
Methodology: https://510kreport.com/methodology