510(k) · Cleared
ClearedExtra Pta Balloon Catheter with Embolic Protection 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 Mar 23, 2010 as substantially equivalent to K023320 (Guidant Corp., 2002) and 2 other predicates after a 403-day review. Its family tree reaches back 6 generations to 2001. 1 of the 21 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it.
- Decided
- Mar 23, 2010
- Review
- 403 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K003992 (2001). 10 ancestors in all. 10 later devices descend from it, 2 citing it directly. 1 of the 21 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK003992 Percusurge Guardwire Temporary Occlusion and Aspiration SystemPercu Surge, Inc. · 2001
- 5 generations backK023691 Boston Scientific Filterwire EX EmbolicBoston Scientific Epi · 2003
- 4 generations backK032884 Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval…Boston Scientific Epi · 2004
- 3 generations backK053195 Spiderx Embolic Protection DeviceEv3, Inc. · 2006
- 2 generations backK062201 Spiderx Embolic Protection DeviceEv3, Inc. · 2006
- 1 generation backK063785 Spiderfx Embolic Protection DeviceEv3, Inc. · 2007
- This deviceK090364 Extra Pta Balloon Catheter with Embolic Protection FeatureAngioslide, Ltd. · 2010
- Descendant · cites it directly · 5 of its ownK111750 Extra Pta Balloon Catheter with Embolic Capture Feature; Proteus Pta…Angioslide, Ltd. · 2011
- Descendant · cites it directly · 4 of its ownK111010 Spiderfx Embolic Protection DeviceEv3, Inc. · 2011
- Descendant · 2 generations on · 3 of its ownK120805 Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd. · 2012
- Descendant · 2 generations on · 2 of its ownK180023 WirionGardia Medical, Ltd. · 2018
- Descendant · 3 generations on · 2 of its ownK133043 Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd. · 2013
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K210282 WIRION Embolic Protection System4 generations on · 2021
Most influential descendants
Showing 5 of 10 · See all- K111750Extra Pta Balloon Catheter with Embolic Capture Feature; Proteus Pta Balloon Catheter…Angioslide, Ltd. · 2011 · cites it directly5descendants
- K111010Spiderfx Embolic Protection DeviceEv3, Inc. · 2011 · cites it directly4descendants
- K120805Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd. · 2012 · 2 generations on3descendants
- K180023WirionGardia Medical, Ltd. · 2018 · 2 generations on2descendants
- K133043Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd. · 2013 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K003992 | Percusurge Guardwire Temporary Occlusion and Aspiration System | Percu Surge, Inc. | 2001 | — |
| −5 | K023691 | Boston Scientific Filterwire EX Embolic | Boston Scientific Epi | 2003 | — |
| −4 | K032884 | Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval Sheath | Boston Scientific Epi | 2004 | — |
| −3 | K053195 | Spiderx Embolic Protection Device | Ev3, Inc. | 2006 | — |
| −2 | K062201 | Spiderx Embolic Protection Device | Ev3, Inc. | 2006 | — |
| −1 | K063785 | Spiderfx Embolic Protection Device | Ev3, Inc. | 2007 | — |
| 0 (this device) | 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 | — |
| +1 | K111010 | Spiderfx Embolic Protection Device | Ev3, Inc. | 2011 | — |
| +2 | K120805 | Proteus Pta Balloon Catheter with Embolic Capture Feature | Angioslide, Ltd. | 2012 | — |
| +2 | K180023 | Wirion | Gardia Medical, Ltd. | 2018 | — |
| +3 | K133043 | Proteus Pta Balloon Catheter with Embolic Capture Feature | Angioslide, Ltd. | 2013 | — |
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 |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 1 |
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.
1 device in this family has a Class I recall. 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? (3)
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 |
|---|---|---|---|
| * | K023320 | Agiltrac .035 Peripheral Dilatation CatheterSummary page 1…el: Cardiovascular Regulation Number: 21 CFR 870.1250 Product Code: LIT, DQY Predicate Devices: 1. AgilTrac .035 Peripheral Dilatation Catheter (K023320) 2. ATB Advance PTA Balloon Catheter (K052036) 3. Spider FX Embolic Protection Device (K(063785)… | 2002 |
| * | K052036 | Atb Advance Pta Dilatation CatheterSummary page 1…870.1250 Product Code: LIT, DQY Predicate Devices: 1. AgilTrac .035 Peripheral Dilatation Catheter (K023320) 2. ATB Advance PTA Balloon Catheter (K052036) 3. Spider FX Embolic Protection Device (K(063785) 510(k) Summary: Angioslide eXtratm PTA Balloon Cathete… | 2005 |
| * | K063785 | Spiderfx Embolic Protection DeviceSummary page 2…t to those of the AgilTrac .035 Peripheral Dilatation Catheter (K023320), the ATB Advance PTA Dilatation Catheter (K052036), and the Spider FX Embolic Protection Device (K063785). Summary of Bench Testing: In vitro bench testing of the Angioslide eXtra Tm PTA Balloon Catheter was conducted in accordance w… | 2007 |
What descends from it? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K210282WIRION Embolic Protection SystemCardiovascular Systems, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K111750 (Angioslide, Ltd., 2011) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K023320.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
Thle Angioslide eXtraTM Percutaneous Transluminal Angioolasty (PTA) Balloon Catheter with Embolic Capture Feature is indicated for peripheral translurninal anaioplasty and for capture and containment of embolic material during angioplasty. for the fernoral. iliac. ilio-femoral. popliteal. tibia]. peroneal, and profunda arteries.
The Angioslide eXtraTM 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/K090364 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090364: Extra Pta Balloon Catheter with Embolic Protection Feature.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090364
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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