510(k) · Cleared
ClearedBASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20 Endovascular Catheter (Ref. 7220), BASHIR Plus 30 Endovascular Catheter (Ref. 7230), BASHIR Plus 40 Endovascular Catheter (Ref. 7240)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thrombolex, Inc. · QEY Mechanical Thrombolysis Catheter
Cleared on Jun 10, 2021 as substantially equivalent to K183290 (Thrombolex, Inc., 2019) and 1 other predicate after a 62-day review. Its family tree reaches back 20 generations to 1990.
- Decided
- Jun 10, 2021
- Review
- 62 days
- Class
- Class II
- Product code
- QEY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 20 generations to K904788 (1990). 51 ancestors in all. No later device cites it as a predicate yet.
- Root · 20 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 16 generations between
- 3 generations backK111705 Ekosonic Endovascular SystemEkos Corporation · 2011 · Recalled
- 2 generations backK183290 Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular…Thrombolex, Inc. · 2019
- 1 generation backK193071 Bashir Plus Endovascular CatheterThrombolex, Inc. · 2019
- This deviceK211061 BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10…Thrombolex, Inc. · 2021
Show all 20 generations
- Root · 20 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 19 generations backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
- 18 generations backK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
- 17 generations backK013635 Trellis Infusion System (10CM Infusion Length); Trellis Infusion…Bacchus Vascular, Inc. · 2002
- 16 generations backK021958 Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc. · 2002 · Recalled
- 15 generations backK023514 Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM…Bacchus Vascular, Inc. · 2002 · Recalled
- 14 generations backK030637 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 13 generations backK033214 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 12 generations backK041629 Lysus Infusion SystemEkos Corp. · 2004
- 11 generations backK042456 Lysus Infusion SystemEkos Corp. · 2004 · Recalled
- 10 generations backK051319 Lysus Infusion SystemEkos Corp. · 2005
- 9 generations backK052071 Lysus Infusion SystemEkos Corp. · 2005
- 8 generations backK060084 Lysus Infusion SystemEkos Corp. · 2006
- 7 generations backK062507 Micro-Infusion SystemEkos Corp. · 2006
- 6 generations backK063620 Ekos Micro-Infusion SystemEkos Corp. · 2007
- 5 generations backK073166 Endowave Infusion SystemEkos Corp. · 2008
- 4 generations backK081467 Ekosonic Endovascular System with Rapid Pulse ModulationEkos Corp. · 2008 · Recalled
- 3 generations backK111705 Ekosonic Endovascular SystemEkos Corporation · 2011 · Recalled
- 2 generations backK183290 Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular…Thrombolex, Inc. · 2019
- 1 generation backK193071 Bashir Plus Endovascular CatheterThrombolex, Inc. · 2019
- This deviceK211061 BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10…Thrombolex, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K904788 | Mewissen Catheter | Boston Scientific Corp | 1990 | — |
| −19 | K974067 | Fountain Infusion Catheter and Occluding Guide Wire | Merit Medical Systems, Inc. | 1998 | 23 |
| −18 | K981417 | Squirt Fluid Delivery System | Merit Medical Systems, Inc. | 1998 | — |
| −17 | K013635 | Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM… | Bacchus Vascular, Inc. | 2002 | — |
| −16 | K021958 | Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM… | Bacchus Vascular, Inc. | 2002 | 1 |
| −15 | K023514 | Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion… | Bacchus Vascular, Inc. | 2002 | 1 |
| −14 | K030637 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| −13 | K033214 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| −12 | K041629 | Lysus Infusion System | Ekos Corp. | 2004 | — |
| −11 | K042456 | Lysus Infusion System | Ekos Corp. | 2004 | 3 |
| −10 | K051319 | Lysus Infusion System | Ekos Corp. | 2005 | — |
| −9 | K052071 | Lysus Infusion System | Ekos Corp. | 2005 | — |
| −8 | K060084 | Lysus Infusion System | Ekos Corp. | 2006 | — |
| −7 | K062507 | Micro-Infusion System | Ekos Corp. | 2006 | — |
| −6 | K063620 | Ekos Micro-Infusion System | Ekos Corp. | 2007 | — |
| −5 | K073166 | Endowave Infusion System | Ekos Corp. | 2008 | — |
| −4 | K081467 | Ekosonic Endovascular System with Rapid Pulse Modulation | Ekos Corp. | 2008 | 5 |
| −3 | K111705 | Ekosonic Endovascular System | Ekos Corporation | 2011 | 5 |
| −2 | K183290 | Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter… | Thrombolex, Inc. | 2019 | — |
| −1 | K193071 | Bashir Plus Endovascular Catheter | Thrombolex, Inc. | 2019 | — |
| 0 (this device) | K211061 | BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter… | Thrombolex, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 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 QEY? 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 QEY device
- #1 K241851 Versus™ Catheter (VS110-8B)score 16.8 · 19 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 |
|---|---|---|---|
| * | K183290 | Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200Summary page 5…Panel: Cardiovascular 3. PREDICATE DEVICE The predicate devices are the BASHIR™ Endovascular Catheter, K183290 and the BASHIR™ Plus Endovascular Catheters, K193071. 1… | 2019 |
| * | K193071 | Bashir Plus Endovascular CatheterSummary page 5…3. PREDICATE DEVICE The predicate devices are the BASHIR™ Endovascular Catheter, K183290 and the BASHIR™ Plus Endovascular Catheters, K193071. 1 K211061 4. DESCRIPTION OF THE DEVICE… | 2019 |
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 31 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 12 of the 51 ancestors have a recall of any class.
- 4 other devices also cite its predicate K183290.
How does its category compare?
All QEY devicesQEY Mechanical Thrombolysis Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · QEY
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QEY
62in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QEY
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QEY
5in 2025
MAUDE reports naming product code QEY, 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 | 5 | 28 | 0 | 0 |
| 2008 | 4 | 54 | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 3 | 144 | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 5 | 91 | 0 | 0 |
| 2020 | 3 | 158 | 0 | 0 |
| 2021 | 3 | 62 | 0 | 0 |
| 2022 | 1 | — | 1 | 0 |
| 2023 | 2 | — | 1 | 1 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The BASHIR™ Endovascular Catheter and the BASHIR™ Plus Endovascular Catheters (BASHIR™+ 10, BASHIR™+20, BASHIR™+30, BASHIR™+40) are intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature, enabling the restoration of blood flow in patients with venous thrombus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211061 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211061: BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20 Endovascular Catheter (Ref. 7220), BASHIR Plus 30 Endovascular Catheter (Ref. 7230), BASHIR Plus 40 Endovascular Catheter (Ref. 7240).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211061
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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