510(k) · Cleared
ClearedTrapper Exchange Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Creganna Medical Aslo Business AS Cregganna Tactx Medical · DQY Catheter, Percutaneous
Cleared on Jan 6, 2017 as substantially equivalent to P860019 (Scimed Life Systems, Inc., 1986) and 1 other predicate after a 149-day review. Its family tree reaches back 2 generations to 1986. 1 later device descends from it.
- Decided
- Jan 6, 2017
- Review
- 149 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to P860019 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backP860019 Scimed Ptca Dilatation CatheterScimed Life Systems, Inc. · 1986 · Recalled
- 1 generation backK113220 Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation…Boston Scientific Corporation · 2012 · Recalled
- This deviceK162253 Trapper Exchange DeviceCreganna Medical Aslo Business AS Cregganna Tactx Medical · 2017
- Descendant · cites it directly · 0 of its ownK191229 TrapItImds Operations B.V. · 2020
Most influential descendants
Showing 1 of 1 · See all- K191229TrapItImds Operations B.V. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P860019 | Scimed Ptca Dilatation Catheter | Scimed Life Systems, Inc. | 1986 | 5 |
| −1 | K113220 | Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter… | Boston Scientific Corporation | 2012 | 1 |
| 0 (this device) | K162253 | Trapper Exchange Device | Creganna Medical Aslo Business AS Cregganna Tactx Medical | 2017 | — |
| +1 | K191229 | TrapIt | Imds Operations B.V. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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? (2)
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 |
|---|---|---|---|
| * | P860019 | Scimed Ptca Dilatation CatheterSummary page 4…undergoing PCI procedures. Trapper Exchange Device is not intended for use outside of the guide catheter. Predicate Devices Boston Scientific Legacy Trapper Device, P860019 S040 (Primary Predicate) Boston Scientific Emerge PTCA Catheter, K113220 Page 1 of 4… | 1986 |
| * | K113220 | Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter (Over-the-Wire)Summary page 4…outside of the guide catheter. Predicate Devices Boston Scientific Legacy Trapper Device, P860019 S040 (Primary Predicate) Boston Scientific Emerge PTCA Catheter, K113220 Page 1 of 4 Parkmore West… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191229 | TrapIt | 2020 | 0 |
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 31 years and passes through 3 companies; a new generation was cleared every 25.3 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K191229 (Imds Operations B.V., 2020) has gone furthest, with 0 descendants of its own.
- 20 other devices also cite its predicate P860019.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
Trapper Exchange Device is indicated to facilitate interventional device exchange while maintaining wire position in patients undergoing PCI procedures. Trapper Exchange Device is not intended for use outside of the guide catheter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162253: Trapper Exchange Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162253
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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