510(k) · Cleared
ClearedAcuity Break-Away Guide Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiac Pacemakers, Inc. · DQY Catheter, Percutaneous
Cleared on Mar 5, 2010 as substantially equivalent to K031505 (Guidant Corporation, 2003) after a 72-day review. Its family tree reaches back 4 generations to 1995. 4 later devices descend from it.
- Decided
- Mar 5, 2010
- Review
- 72 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K953987 (1995). 5 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK953987 Acs Tourgide Guiding CatheterAdvanced Cardiovascular Systems, Inc. · 1995
- 3 generations backK021284 Easytrak Guiding CatheterGuidant Corp. · 2002 · Recalled
- 2 generations backK021455 Rapido Guiding Catheter, 6F Model# 6776; Rapido Guiding Catheter, 8F…Guidant Corp. · 2002 · Recalled
- 1 generation backK031505 Rapido Cut-Away Guiding CatheterGuidant Corporation · 2003 · Recalled
- This deviceK093969 Acuity Break-Away Guide CatheterCardiac Pacemakers, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK111252 Acuity (TM) Cut-Away (TM) Guide Catheters 6F and 8FBoston Scientific Corp · 2011
- Descendant · cites it directly · 2 of its ownK132914 Acuity Pro Lead Delivery SystemBoston Scientific · 2014 · Recalled
- Descendant · 2 generations on · 1 of its ownK171612 ACUITY Pro Lead Delivery SystemBoston Scientific Corporation · 2017
- Descendant · 3 generations on · 0 of its ownK243757 Shockwave CS Guide CatheterShockwave Medical, Inc. · 2025
Most influential descendants
Showing 4 of 4 · See all- K111252Acuity (TM) Cut-Away (TM) Guide Catheters 6F and 8FBoston Scientific Corp · 2011 · cites it directly3descendants
- K132914Acuity Pro Lead Delivery SystemBoston Scientific · 2014 · cites it directly2descendants
- K171612ACUITY Pro Lead Delivery SystemBoston Scientific Corporation · 2017 · 2 generations on1descendant
- K243757Shockwave CS Guide CatheterShockwave Medical, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953987 | Acs Tourgide Guiding Catheter | Advanced Cardiovascular Systems, Inc. | 1995 | — |
| −3 | K021284 | Easytrak Guiding Catheter | Guidant Corp. | 2002 | 17 |
| −2 | K021455 | Rapido Guiding Catheter, 6F Model# 6776; Rapido Guiding Catheter, 8F Model#… | Guidant Corp. | 2002 | 18 |
| −1 | K031505 | Rapido Cut-Away Guiding Catheter | Guidant Corporation | 2003 | 1 |
| 0 (this device) | K093969 | Acuity Break-Away Guide Catheter | Cardiac Pacemakers, Inc. | 2010 | — |
| +1 | K111252 | Acuity (TM) Cut-Away (TM) Guide Catheters 6F and 8F | Boston Scientific Corp | 2011 | — |
| +1 | K132914 | Acuity Pro Lead Delivery System | Boston Scientific | 2014 | 1 |
| +2 | K171612 | ACUITY Pro Lead Delivery System | Boston Scientific Corporation | 2017 | — |
| +3 | K243757 | Shockwave CS Guide Catheter | Shockwave Medical, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2025 | 1 | 0 |
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.
Planning a device in DQY? 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? (1)
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 |
|---|---|---|---|
| * | K031505 | Rapido Cut-Away Guiding Catheter | 2003 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 6.4 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K111252 (Boston Scientific Corp, 2011) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K031505.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 ACUITY Break-Away™ Lead Delivery System is intended to access the coronary venous system and may be used alone (8F) or in dual catheter delivery (8F with 6F). The system serves as a conduit for the delivery of contrast medium and devices, including implantable coronary venous leads, introduced into the coronary venous system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093969 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093969: Acuity Break-Away Guide Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093969
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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