510(k) · Cleared
ClearedEnvoy Distal Access Guiding Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Codman & Shurtleff, Inc. · DQY Catheter, Percutaneous
Cleared on Feb 24, 2012 after a 30-day review. The FDA summary names its predicate without a number. 1 of the 6 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Feb 24, 2012
- Review
- 30 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- This deviceK120229 Envoy Distal Access Guiding CatheterCodman & Shurtleff, Inc. · 2012
- Descendant · cites it directly · 4 of its ownK140080 Envoy Distal Access (DA) Guiding Catheter, 6F, 95CM & 105CM…Codman & Shurtleff, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK162563 YOGA MicrocatheterCodman & Shurtleff, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK201076 Anchor Dual Lumen Guidewire CatheterAqure Medical, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK192804 CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm…Medos International SARL · 2020 · Recalled (Class I)
- Descendant · 3 generations on · 0 of its ownK171653 YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back UpCodman & Shurtleff, Inc. · 2017
Class I recalls in this family
- K192804 CEREBASE DA Guide Sheath, 95cm, CEREBASE DA…2 generations on · 2020
Most influential descendants
Showing 5 of 5 · See all- K140080Envoy Distal Access (DA) Guiding Catheter, 6F, 95CM & 105CM, Straight & XB, MPD & XB…Codman & Shurtleff, Inc. · 2014 · cites it directly4descendants
- K162563YOGA MicrocatheterCodman & Shurtleff, Inc. · 2017 · 2 generations on1descendant
- K201076Anchor Dual Lumen Guidewire CatheterAqure Medical, Inc. · 2020 · 2 generations on0descendants
- K192804CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide…Medos International SARL · 2020 · 2 generations on0descendants
- K171653YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back UpCodman & Shurtleff, Inc. · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K120229 | Envoy Distal Access Guiding Catheter | Codman & Shurtleff, Inc. | 2012 | — |
| +1 | K140080 | Envoy Distal Access (DA) Guiding Catheter, 6F, 95CM & 105CM, Straight & XB… | Codman & Shurtleff, Inc. | 2014 | — |
| +2 | K162563 | YOGA Microcatheter | Codman & Shurtleff, Inc. | 2017 | — |
| +2 | K201076 | Anchor Dual Lumen Guidewire Catheter | Aqure Medical, Inc. | 2020 | — |
| +2 | K192804 | CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA… | Medos International SARL | 2020 | Class I |
| +3 | K171653 | YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up | Codman & Shurtleff, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 2 | 1 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | ENVOY Guiding Catheter Named without a submission number | |
| * | — | Neuropath Guiding Catheter Named without a submission number | |
| * | — | REVIVE Intermediate Catheter Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140080 | Envoy Distal Access (DA) Guiding Catheter, 6F, 95CM & 105CM, Straight & XB, MPD & XB… | 2014 | 4 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K192804CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA…Medos International SARL · 2020 · 2 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K140080 (Codman & Shurtleff, Inc., 2014) has gone furthest, with 4 descendants of its own.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
The Envoy Distal Access Guiding Catheter is intended for use in the peripheral, coronary; and neurovasculature for the intravascular introduction of interventional/diagnostic devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120229 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120229: Envoy Distal Access Guiding Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120229
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026