# K984260: Pinnacle R/O or Redifocus Introducer R/O (Comprised of a Sheath & Dilator)

- Pathway: 510(k) (Special)
- Applicant: Terumo Medical Corp.
- Decided: Jan 26, 1999 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 K954234 (1995). 1 ancestor in all.
23 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954234: Radifocus Introducer II Kit, Terumo Medical Corp. (1995) Summary page 1.

## Most influential descendants
- K022170: Inner-Lock Locking Introducer Sheaths (2003), 16 descendants of its own
- K032569: Short Introducer Sheath (2003), 15 descendants of its own
- K033793: Cleaner II Rotational Thrombectomy System (2003), 12 descendants of its own
- K040252: Cleaner Rotational Thrombectomy System Kit (2004), 11 descendants of its own
- K060904: Cleaner Rotational Thrombectomy System (2006), 10 descendants of its own

## Indications for use
The PINNACLE R/O 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/K984260
Methodology: https://510kreport.com/methodology