510(k) · Cleared
ClearedExtra Pta Balloon Catheter with Embolic Capture Feature; Proteus Pta Balloon Catheter with Embolic Capture Feature
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Angioslide, Ltd. · DQY Catheter, Percutaneous
Cleared on Jul 21, 2011 as substantially equivalent to K090364 (Angioslide, Ltd., 2010) after a 29-day review. Its family tree reaches back 7 generations to 2001. 5 later devices descend from it.
- Decided
- Jul 21, 2011
- Review
- 29 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K003992 (2001). 11 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK003992 Percusurge Guardwire Temporary Occlusion and Aspiration SystemPercu Surge, Inc. · 2001
- 6 generations backK023691 Boston Scientific Filterwire EX EmbolicBoston Scientific Epi · 2003
- 5 generations backK032884 Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval…Boston Scientific Epi · 2004
- 4 generations backK053195 Spiderx Embolic Protection DeviceEv3, Inc. · 2006
- 3 generations backK062201 Spiderx Embolic Protection DeviceEv3, Inc. · 2006
- 2 generations backK063785 Spiderfx Embolic Protection DeviceEv3, Inc. · 2007
- 1 generation backK090364 Extra Pta Balloon Catheter with Embolic Protection FeatureAngioslide, Ltd. · 2010
- This deviceK111750 Extra Pta Balloon Catheter with Embolic Capture Feature; Proteus Pta…Angioslide, Ltd. · 2011
- Descendant · cites it directly · 3 of its ownK120805 Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd. · 2012
- Descendant · 2 generations on · 2 of its ownK133043 Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd. · 2013
- Descendant · 3 generations on · 1 of its ownK172494 PROTEUS PTA Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd. · 2017
- Descendant · 4 generations on · 0 of its ownK181529 Vanguard IEP Peripheral Balloon Angioplasty System with Integrated…Contego Medical, LLC · 2018
- Descendant · cites it directly · 0 of its ownK120164 Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd. · 2012
Most influential descendants
Showing 5 of 5 · See all- K120805Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd. · 2012 · cites it directly3descendants
- K133043Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd. · 2013 · 2 generations on2descendants
- K172494PROTEUS PTA Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd. · 2017 · 3 generations on1descendant
- K181529Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic ProtectionContego Medical, LLC · 2018 · 4 generations on0descendants
- K120164Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K003992 | Percusurge Guardwire Temporary Occlusion and Aspiration System | Percu Surge, Inc. | 2001 | — |
| −6 | K023691 | Boston Scientific Filterwire EX Embolic | Boston Scientific Epi | 2003 | — |
| −5 | K032884 | Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval Sheath | Boston Scientific Epi | 2004 | — |
| −4 | K053195 | Spiderx Embolic Protection Device | Ev3, Inc. | 2006 | — |
| −3 | K062201 | Spiderx Embolic Protection Device | Ev3, Inc. | 2006 | — |
| −2 | K063785 | Spiderfx Embolic Protection Device | Ev3, Inc. | 2007 | — |
| −1 | K090364 | Extra Pta Balloon Catheter with Embolic Protection Feature | Angioslide, Ltd. | 2010 | — |
| 0 (this device) | K111750 | Extra Pta Balloon Catheter with Embolic Capture Feature; Proteus Pta Balloon… | Angioslide, Ltd. | 2011 | — |
| +1 | K120805 | Proteus Pta Balloon Catheter with Embolic Capture Feature | Angioslide, Ltd. | 2012 | — |
| +2 | K133043 | Proteus Pta Balloon Catheter with Embolic Capture Feature | Angioslide, Ltd. | 2013 | — |
| +3 | K172494 | PROTEUS PTA Balloon Catheter with Embolic Capture Feature | Angioslide, Ltd. | 2017 | — |
| +4 | K181529 | Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic… | Contego Medical, LLC | 2018 | — |
| +1 | K120164 | Proteus Pta Balloon Catheter with Embolic Capture Feature | Angioslide, Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K090364 | Extra Pta Balloon Catheter with Embolic Protection FeatureSummary page 1…s claimed to be substantially equivalent to the following legally marketed predicate device: * Angioslide eXtraTM PTA Balloon Catheter with Embolic Capture Feature (K090364) Device Description: The PROTEUSTM PTA Balloon Catheter with Embolic Capture Feature is an over the wire co- axial dual lumen cat… | 2010 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 10 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K120805 (Angioslide, Ltd., 2012) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K090364.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Angioslide PROTEUS Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is indicated for peripheral transluminal angioplasty and for capture and containment of embolic material during angioplasty, for the femoral, iliac, ilio-femoral, popliteal, tibial, peroneal, and profunda arteries.
The Angioslide PROTEUS PTA Balloon Catheter with Embolic Capture Feature is not intended for use in the renal, cerebral, coronary or carotid vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111750 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111750: Extra Pta Balloon Catheter with Embolic Capture Feature; Proteus Pta Balloon Catheter with Embolic Capture Feature.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111750
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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