# K120229: Envoy Distal Access Guiding Catheter

- Pathway: 510(k) (Special)
- Applicant: Codman & Shurtleff, Inc.
- Decided: Feb 24, 2012 after 30 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.
5 later devices descend from it; 1 cites it directly.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ENVOY Guiding Catheter: named in the summary without a submission number
- (no number) Neuropath Guiding Catheter: named in the summary without a submission number
- (no number) REVIVE Intermediate Catheter: named in the summary without a submission number

## Most influential descendants
- K140080: Envoy Distal Access (DA) Guiding Catheter, 6F, 95CM & 105CM, Straight & XB, MPD & XB, MPC & XB (2014), 4 descendants of its own
- K162563: YOGA Microcatheter (2017), 1 descendant of its own
- K201076: Anchor Dual Lumen Guidewire Catheter (2020), 0 descendants of its own
- K192804: CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cm (2020), 0 descendants of its own
- K171653: YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up (2017), 0 descendants of its own

## Indications for use
The Envoy Distal Access Guiding Catheter is intended for use in the peripheral, coronary; and neurovasculature for the intravascular introduction of interventional/diagnostic devices.

Source page: https://510kreport.com/device/K120229
Methodology: https://510kreport.com/methodology