510(k) · Cleared
ClearedPercupro Messenger Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiosolutions, Inc. · DYG Catheter, Flow Directed
Cleared on Jul 14, 2011 as substantially equivalent to K051137 (Techdevice Corporation, 2006) and 3 other predicates after a 560-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- Jul 14, 2011
- Review
- 560 days
- Class
- Class II
- Product code
- DYG
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K021721 (2002). 6 ancestors in all, the oldest K911710 (1991). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K021721 | Equalizer Balloon Catheter | Boston Scientific Corp | 2002 | 4 |
| −1 | K051137 | Techdevice Occlusion Balloon Catheter | Techdevice Corporation | 2006 | 1 |
| 0 (this device) | K094048 | Percupro Messenger Balloon Catheter | Cardiosolutions, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2010 | 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 DYG? 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 DYG device
- #1 K242451 HemoSphere Alta Advanced Monitoring Platform…score 24.2 · 39 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K051137 | Techdevice Occlusion Balloon CatheterSummary page 1…CFR 870.1240 Class 2 Panel Circulatory System Devices Panel Predicate Devices TechiDevrice Percutaneous Occlusion Balloon Catheter K05 1137 Boston Scientific Schneider GuiderTm SoftipTM Guiding Catheter K<96 1999, K010853 B… | 2006 |
| * | K961999 | Schneider Guider Softip Guiding CathetersSummary page 2…The Percu-ProTN' Messenger Balloon Catheter has the same intended use as the Boston Scientific Schneider"4 SoftipTNM Guiding Catheter( K96 1999), is made from similar materials. and is similar in length and diameter. Both devices have multi-lumen to… | 1996 |
| * | K010853 | Guider Softip Guiding Catheter XF 5FSummary page 1…evices TechiDevrice Percutaneous Occlusion Balloon Catheter K05 1137 Boston Scientific Schneider GuiderTm SoftipTM Guiding Catheter K<96 1999, K010853 Biosensorsfinernational Flow Directed Thermodilution Catheter K<083384… | 2001 |
| * | K083384 | Thermodilution Catheter Cleared while this submission was under review Summary page 2…er tip positioning. This intended use and design feature are substantially equivalent to the Biosensors Thermiodilution Catheter (K083384) wvhich defines a balloon tip to allow for flow direction for catheter tip positioning in their intended use… | 2010 |
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 9 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- 3 of the 6 ancestors have a recall of any class.
How does its category compare?
All DYG devicesDYG Catheter, Flow Directed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DYG
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DYG
188in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYG
2in 2019
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · DYG
268in 2025
MAUDE reports naming product code DYG, 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 | 0 | — | 1 | 168 |
| 2008 | 1 | — | 0 | 400 |
| 2009 | 0 | — | 3 | 145 |
| 2010 | 0 | — | 0 | 147 |
| 2011 | 1 | — | 0 | 249 |
| 2012 | 0 | — | 0 | 221 |
| 2013 | 0 | — | 1 | 149 |
| 2014 | 0 | — | 0 | 178 |
| 2015 | 0 | — | 0 | 163 |
| 2016 | 1 | — | 0 | 154 |
| 2017 | 0 | — | 0 | 115 |
| 2018 | 0 | — | 4 (4) | 133 |
| 2019 | 0 | — | 2 | 144 |
| 2020 | 1 | — | 0 | 104 |
| 2021 | 0 | — | 0 | 97 |
| 2022 | 1 | — | 0 | 130 |
| 2023 | 1 | — | 0 | 229 |
| 2024 | 3 | 188 | 0 | 226 |
| 2025 | 0 | — | 0 | 268 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The Percu-ProTM Messenger Balloon Catheter is intended to facilitate the placement of interventional devices during diagnostic and interventional cardiovascular procedures. The device is not intended for coronary or neurovascular use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K094048 · printed Nov 6, 2026
Cite this page
510(k) Report. “K094048: Percupro Messenger Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K094048
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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