510(k) · Cleared
ClearedBoss Crossing Support Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Marvao Medical Devices, Ltd. · DQY Catheter, Percutaneous
Cleared on Jun 2, 2022 as substantially equivalent to K173799 (Terumo Corporation, 2018) and 1 other predicate after a 90-day review. Its family tree reaches back 9 generations to 1994.
- Decided
- Jun 2, 2022
- Review
- 90 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K935425 (1994). 15 ancestors in all, the oldest K863137 (1986). No later device cites it as a predicate yet.
- Root · 9 generations backK935425 Metronic Buchbinder Envoy Percutaneous CathetersMedtronics Interventional Vascular · 1994
- 5 generations between
- 3 generations backK092396 Spectranetics Quick Cross Extreme Support CathetersSpectranetics Corp. · 2009
- 2 generations backK110540 Terumo Support CatheterTerumo Medical Corp. · 2011
- 1 generation backK173799 NaviCross 0.018Terumo Corporation · 2018
- This deviceK220632 Boss Crossing Support CatheterMarvao Medical Devices, Ltd. · 2022
Show all 9 generations
- Root · 9 generations backK935425 Metronic Buchbinder Envoy Percutaneous CathetersMedtronics Interventional Vascular · 1994
- 8 generations backK991059 Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics…Spectranetics Corp. · 1999
- 7 generations backK022138 Spectranetics 0.035 Support Catheter, Model 518-028Spectranetics Corp. · 2002
- 6 generations backK033678 Spectranetics Quick Cross Catheters, Models 518-032, 518-033…Spectranetics Corp. · 2004
- 5 generations backK072750 Spectranetics Quick-Cross SUPPORT2 Catheters, Models 518-065 and…Spectranetics Corp. · 2007
- 4 generations backK082561 Spectranetics Quick-Cross Extreme Support CathetersSpectranetics Corp. · 2008
- 3 generations backK092396 Spectranetics Quick Cross Extreme Support CathetersSpectranetics Corp. · 2009
- 2 generations backK110540 Terumo Support CatheterTerumo Medical Corp. · 2011
- 1 generation backK173799 NaviCross 0.018Terumo Corporation · 2018
- This deviceK220632 Boss Crossing Support CatheterMarvao Medical Devices, Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K935425 | Metronic Buchbinder Envoy Percutaneous Catheters | Medtronics Interventional Vascular | 1994 | — |
| −8 | K991059 | Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018… | Spectranetics Corp. | 1999 | — |
| −7 | K022138 | Spectranetics 0.035 Support Catheter, Model 518-028 | Spectranetics Corp. | 2002 | — |
| −6 | K033678 | Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035… | Spectranetics Corp. | 2004 | — |
| −5 | K072750 | Spectranetics Quick-Cross SUPPORT2 Catheters, Models 518-065 and 518-066 | Spectranetics Corp. | 2007 | — |
| −4 | K082561 | Spectranetics Quick-Cross Extreme Support Catheters | Spectranetics Corp. | 2008 | — |
| −3 | K092396 | Spectranetics Quick Cross Extreme Support Catheters | Spectranetics Corp. | 2009 | — |
| −2 | K110540 | Terumo Support Catheter | Terumo Medical Corp. | 2011 | — |
| −1 | K173799 | NaviCross 0.018 | Terumo Corporation | 2018 | — |
| 0 (this device) | K220632 | Boss Crossing Support Catheter | Marvao Medical Devices, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 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 |
|---|---|---|---|
| * | K173799 | NaviCross 0.018Summary page 5…The proposed device is substantially equivalent in regard to design and materials to the predicate Terumo NaviCross Support catheters 510(k) K110540 (0.035”) and 510(k) K173799 (0.018”) device. Performance Testing Bench testing was completed to assure the device performed as intended in a… | 2018 |
| * | K110540 | Terumo Support CatheterSummary page 4…Terumo NaviCross Support Catheter K173779 (0.018”) and 510(k) Number: Reference Device: Terumo NaviCross Support Catheter K110540 (0.035”) Device Description The Boss Crossing Support Catheter (Boss CSC) is intended to guide and support a guidewire during a… | 2011 |
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 28 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 15 ancestors has a recall of any class.
- 1 other device also cites its predicate K173799.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Boss Crossing Support Catheter (Boss CSC) is indicated to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or diagnostic contrast agents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220632 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220632: Boss Crossing Support Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220632
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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