510(k) · Cleared
ClearedShockwave CS Guide Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shockwave Medical, Inc. · DQY Catheter, Percutaneous
Cleared on May 2, 2025 as substantially equivalent to K171612 (Boston Scientific Corporation, 2017) after a 147-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- May 2, 2025
- Review
- 147 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K953987 (1995). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK953987 Acs Tourgide Guiding CatheterAdvanced Cardiovascular Systems, Inc. · 1995
- 7 generations backK021284 Easytrak Guiding CatheterGuidant Corp. · 2002 · Recalled
- 6 generations backK021455 Rapido Guiding Catheter, 6F Model# 6776; Rapido Guiding Catheter, 8F…Guidant Corp. · 2002 · Recalled
- 5 generations backK031505 Rapido Cut-Away Guiding CatheterGuidant Corporation · 2003 · Recalled
- 4 generations backK093969 Acuity Break-Away Guide CatheterCardiac Pacemakers, Inc. · 2010
- 3 generations backK111252 Acuity (TM) Cut-Away (TM) Guide Catheters 6F and 8FBoston Scientific Corp · 2011
- 2 generations backK132914 Acuity Pro Lead Delivery SystemBoston Scientific · 2014 · Recalled
- 1 generation backK171612 ACUITY Pro Lead Delivery SystemBoston Scientific Corporation · 2017
- This deviceK243757 Shockwave CS Guide CatheterShockwave Medical, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K953987 | Acs Tourgide Guiding Catheter | Advanced Cardiovascular Systems, Inc. | 1995 | — |
| −7 | K021284 | Easytrak Guiding Catheter | Guidant Corp. | 2002 | 17 |
| −6 | K021455 | Rapido Guiding Catheter, 6F Model# 6776; Rapido Guiding Catheter, 8F Model#… | Guidant Corp. | 2002 | 18 |
| −5 | K031505 | Rapido Cut-Away Guiding Catheter | Guidant Corporation | 2003 | 1 |
| −4 | K093969 | Acuity Break-Away Guide Catheter | Cardiac Pacemakers, Inc. | 2010 | — |
| −3 | K111252 | Acuity (TM) Cut-Away (TM) Guide Catheters 6F and 8F | Boston Scientific Corp | 2011 | — |
| −2 | K132914 | Acuity Pro Lead Delivery System | Boston Scientific | 2014 | 1 |
| −1 | K171612 | ACUITY Pro Lead Delivery System | Boston Scientific Corporation | 2017 | — |
| 0 (this device) | 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 |
| 2002 | 1 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K171612 | ACUITY Pro Lead Delivery SystemSummary page 5…ass: II Product Code: DQY III. PREDICATE Boston Scientific Acuity Pro Lead Delivery System (K171612) IV. DEVICE DESCRIPTION The Shockwave CS Guide Catheter is a single lumen catheter consisting of a PTFE liner… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 8 companies; a new generation was cleared every 3.2 years on median.
- 5 of the 11 ancestors have a recall of any class.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Shockwave CS Guide Catheter is intended to access the coronary venous system and may be used alone (9F) or in a dual catheter delivery (e.g., 9F with 7F). The catheter serves as a conduit for the introduction of interventional/diagnostic devices introduced into the coronary venous system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243757 · printed Nov 4, 2026
Cite this page
510(k) Report. “K243757: Shockwave CS 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/K243757
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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