510(k) · Cleared
ClearedProteus 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. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Jun 8, 2012 as substantially equivalent to K111750 (Angioslide, Ltd., 2011) after a 141-day review. Its family tree reaches back 8 generations to 2001.
- Decided
- Jun 8, 2012
- Review
- 141 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K003992 (2001). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK003992 Percusurge Guardwire Temporary Occlusion and Aspiration SystemPercu Surge, Inc. · 2001
- 7 generations backK023691 Boston Scientific Filterwire EX EmbolicBoston Scientific Epi · 2003
- 6 generations backK032884 Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval…Boston Scientific Epi · 2004
- 5 generations backK053195 Spiderx Embolic Protection DeviceEv3, Inc. · 2006
- 4 generations backK062201 Spiderx Embolic Protection DeviceEv3, Inc. · 2006
- 3 generations backK063785 Spiderfx Embolic Protection DeviceEv3, Inc. · 2007
- 2 generations backK090364 Extra Pta Balloon Catheter with Embolic Protection FeatureAngioslide, Ltd. · 2010
- 1 generation backK111750 Extra Pta Balloon Catheter with Embolic Capture Feature; Proteus Pta…Angioslide, Ltd. · 2011
- This deviceK120164 Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K003992 | Percusurge Guardwire Temporary Occlusion and Aspiration System | Percu Surge, Inc. | 2001 | — |
| −7 | K023691 | Boston Scientific Filterwire EX Embolic | Boston Scientific Epi | 2003 | — |
| −6 | K032884 | Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval Sheath | Boston Scientific Epi | 2004 | — |
| −5 | K053195 | Spiderx Embolic Protection Device | Ev3, Inc. | 2006 | — |
| −4 | K062201 | Spiderx Embolic Protection Device | Ev3, Inc. | 2006 | — |
| −3 | K063785 | Spiderfx Embolic Protection Device | Ev3, Inc. | 2007 | — |
| −2 | K090364 | Extra Pta Balloon Catheter with Embolic Protection Feature | Angioslide, Ltd. | 2010 | — |
| −1 | K111750 | Extra Pta Balloon Catheter with Embolic Capture Feature; Proteus Pta Balloon… | Angioslide, Ltd. | 2011 | — |
| 0 (this device) | 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 |
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 LIT? 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 LIT device
- #1 K241040 Amethyst HP PTA OTW 0.035 Catheterscore 13.9 · 9 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 |
|---|---|---|---|
| * | K111750 | Extra Pta Balloon Catheter with Embolic Capture Feature; Proteus Pta Balloon Catheter…Summary page 10…formance characteristics to the following legally marketed predicate device: *PROTEUSTM PTA Balloon Catheter with Embolic Capture Feature, Angioslide - K1 11750 Page: '7- 10 of II DEPARTMENT OF HEALTH & HUMAN SE RVICES… | 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 11 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 12 ancestors has a recall of any class.
- 1 other device also cites its predicate K111750.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · LIT
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LIT
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LIT
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LIT
2,073in 2025
MAUDE reports naming product code LIT, 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 | 6 | 64 | 0 | 577 |
| 2008 | 8 | 53 | 0 | 513 |
| 2009 | 7 | 29 | 2 | 623 |
| 2010 | 13 | 78 | 1 | 809 |
| 2011 | 10 | 82 | 0 | 857 |
| 2012 | 19 | 29 | 0 | 1,277 |
| 2013 | 14 | 79 | 2 (2) | 1,242 |
| 2014 | 12 | 90 | 3 | 1,178 |
| 2015 | 19 | 112 | 0 | 1,279 |
| 2016 | 11 | 116 | 1 | 1,529 |
| 2017 | 9 | 57 | 0 | 2,081 |
| 2018 | 6 | 118 | 2 | 2,188 |
| 2019 | 4 | 40 | 3 | 2,405 |
| 2020 | 9 | 125 | 0 | 2,443 |
| 2021 | 4 | 61 | 1 | 2,492 |
| 2022 | 8 | 122 | 0 | 2,155 |
| 2023 | 6 | 167 | 0 | 1,807 |
| 2024 | 6 | 43 | 2 | 1,913 |
| 2025 | 3 | 90 | 1 | 2,073 |
| 2026 | 4 | 205 | 0 | — |
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K120164 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120164: 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 4, 2026. https://510kreport.com/device/K120164
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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