# K012812: Carotid Guiding Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: Nov 14, 2001 after 84 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K924607 (1993). 1 ancestor in all.
69 later devices descend from it; 3 cite it directly.
2 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924607: Arrow Fischell Kink Resist Percut Sheath Intro Set, Arrow Intl., Inc. (1993) Summary page 1.

## Most influential descendants
- K051601: Pinnacle Destination Peripheral Guiding Sheath (2005), 60 descendants of its own
- 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

## Recalls of this device
- Jun 24, 2010 · Not classified · Z-2415-2011: Molding defect in destination product that render the device unusable.

## Indications for use
The Carotid Guiding Sheath is intended for the introduction of interventional and diagnostic devices into the human vasculature including but not limited to the carotid arteries.

Source page: https://510kreport.com/device/K012812
Methodology: https://510kreport.com/methodology