# K003085: Concentric Guide Catheter, Models 90018, 90020

- Pathway: 510(k) (Traditional)
- Applicant: Concentric Medical, Inc.
- Decided: Mar 7, 2001 after 155 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
2 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K070770: Gore Balloon Sheath (2007), 6 descendants of its own
- K083300: Gore Flow Reversal System (2009), 5 descendants of its own
- K143072: ENROUTE Transcarotid Neuroprotection System (2015), 2 descendants of its own
- K153485: ENROUTE Transcarotid Neuroprotection System (2016), 1 descendant of its own
- K230402: ENROUTE® Transcarotid Neuroprotection System (2023), 0 descendants of its own

Source page: https://510kreport.com/device/K003085
Methodology: https://510kreport.com/methodology