# K062446: Modification to Pinnacle Roii Hiflow Introducer Sheath

- Pathway: 510(k) (Special)
- Applicant: Terumo Medical Corp.
- Decided: Oct 23, 2006 after 62 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 K003424 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003424: Pinnacle R/O II or Radifocus Introducer II, Terumo Medical Corp. (2000) Summary page 2.

## Indications for use
The Pinnacle® ROll HiFlow Introducer Sheath is used to facilitate placing a catheter through the skin into a vein or artery. The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery. The RADIFOCUS Obturator is also an accessory device which is used by placing it into the sheath to create an occlusion and further provide support to the wall of the indwelling sheath while it remains in place within the vein or artery after removal of a catheter.

Source page: https://510kreport.com/device/K062446
Methodology: https://510kreport.com/methodology