510(k) · Cleared
ClearedMicrus Ascent Occlusion Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micrus Endovascular Corporation · MJN Catheter, Intravascular Occluding, Temporary
Cleared on Aug 27, 2008 as substantially equivalent to K011656 (Micro Therapeutics, Inc., 2001) and 3 other predicates after a 153-day review. Its family tree reaches back 3 generations to 1996. 4 later devices descend from it.
- Decided
- Aug 27, 2008
- Review
- 153 days
- Class
- Class II
- Product code
- MJN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K960806 (1996). 12 ancestors in all, the oldest K781772 (1979). 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
- 2 generations backK032624 Micrus MicrocatheterMicrus Corp. · 2003
- 1 generation backK060116 Micrus Courier MicrocathetersMicrus Endovascular Corporation · 2006
- This deviceK080861 Micrus Ascent Occlusion Balloon CatheterMicrus Endovascular Corporation · 2008
- Descendant · cites it directly · 3 of its ownK091504 Micrus Ascent Occlusion Balloon Catheter 4X7MM,6X9MM, Micrus Summit…Micrus Endovascular Corporation · 2009
- Descendant · 2 generations on · 2 of its ownK103780 Micrus Ascent Occlusion Balloon Catheter 4X7 MM; Micrus Ascent…Micrus Endovascular Corporation · 2011
- Descendant · 3 generations on · 1 of its ownK142692 Occlusion Balloon CatheterEmbolx, Inc. · 2015
- Descendant · 4 generations on · 0 of its ownK180904 Sniper Infusion Catheter with Balloon OcclusionEmbolx, Inc. · 2018
Most influential descendants
Showing 4 of 4 · See all- K091504Micrus Ascent Occlusion Balloon Catheter 4X7MM,6X9MM, Micrus Summit Occlusion Balloon…Micrus Endovascular Corporation · 2009 · cites it directly3descendants
- K103780Micrus Ascent Occlusion Balloon Catheter 4X7 MM; Micrus Ascent Occlusion Balloon…Micrus Endovascular Corporation · 2011 · 2 generations on2descendants
- K142692Occlusion Balloon CatheterEmbolx, Inc. · 2015 · 3 generations on1descendant
- K180904Sniper Infusion Catheter with Balloon OcclusionEmbolx, Inc. · 2018 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960806 | Turbo Tracker | Target Therapeutics | 1996 | — |
| −2 | K032624 | Micrus Microcatheter | Micrus Corp. | 2003 | — |
| −1 | K060116 | Micrus Courier Microcatheters | Micrus Endovascular Corporation | 2006 | — |
| 0 (this device) | K080861 | Micrus Ascent Occlusion Balloon Catheter | Micrus Endovascular Corporation | 2008 | — |
| +1 | K091504 | Micrus Ascent Occlusion Balloon Catheter 4X7MM,6X9MM, Micrus Summit Occlusion… | Micrus Endovascular Corporation | 2009 | — |
| +2 | K103780 | Micrus Ascent Occlusion Balloon Catheter 4X7 MM; Micrus Ascent Occlusion… | Micrus Endovascular Corporation | 2011 | — |
| +3 | K142692 | Occlusion Balloon Catheter | Embolx, Inc. | 2015 | — |
| +4 | K180904 | Sniper Infusion Catheter with Balloon Occlusion | Embolx, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 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 MJN? 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 MJN device
- #1 K243795 pREBOA-PRO Catheterscore 12.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K011656 | Hyperform Occlusion Balloon System, Model 104-4470, 104-4471, 104-4770, 104-4771 | 2001 |
| * | K984214 | Cordis Endovascular Temporary Occlusion Balloon CatheterSummary page 1…M Occlusion Balloon Catheter Generic/Common Name: catheter, intravascular occluding, temporary (21CFR § 870.4450) PREDICATE DEVICES * 510(k) no. K984214, Cordis Temporary Occlusion Balloon Catheter, Aug 10, 1999 * 510(k) no. K993292, Sentry Occlusion Balloon Catheter, May 23, 2… | 1999 |
| * | K993292 | Boston Scientific/Target Sentry Occlusion Balloon CatheterSummary page 1…ascular occluding, temporary (21CFR § 870.4450) PREDICATE DEVICES * 510(k) no. K984214, Cordis Temporary Occlusion Balloon Catheter, Aug 10, 1999 * 510(k) no. K993292, Sentry Occlusion Balloon Catheter, May 23, 2000 * 510(k) no. KO11656, MTI Hyperform Occlusion Balloon Catheter, Jun 20, 2001… | 2000 |
| * | K060116 | Micrus Courier MicrocathetersSummary page 1…* 510(k) no. K993292, Sentry Occlusion Balloon Catheter, May 23, 2000 * 510(k) no. KO11656, MTI Hyperform Occlusion Balloon Catheter, Jun 20, 2001 * 510(k) no. K060116, Courier Straight Microcatheter, May 12, 2006 INTENDED USE The Micrus Ascent Occlusion Balloon Catheter is intended for use in… | 2006 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091504 | Micrus Ascent Occlusion Balloon Catheter 4X7MM,6X9MM, Micrus Summit Occlusion Balloon… | 2009 | 3 |
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 12 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K091504 (Micrus Endovascular Corporation, 2009) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K011656.
How does its category compare?
All MJN devicesMJN Catheter, Intravascular Occluding, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MJN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MJN
116in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MJN
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MJN
194in 2025
MAUDE reports naming product code MJN, 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 | 2 | — | 0 | 25 |
| 2008 | 3 | 153 | 2 | 26 |
| 2009 | 5 | 39 | 0 | 25 |
| 2010 | 5 | 30 | 1 | 35 |
| 2011 | 4 | 69 | 1 | 92 |
| 2012 | 2 | — | 0 | 53 |
| 2013 | 4 | 87 | 8 | 76 |
| 2014 | 2 | — | 0 | 100 |
| 2015 | 4 | 245 | 1 | 90 |
| 2016 | 3 | 110 | 2 | 71 |
| 2017 | 3 | 54 | 0 | 157 |
| 2018 | 3 | 63 | 1 | 107 |
| 2019 | 3 | 117 | 0 | 139 |
| 2020 | 4 | 64 | 1 | 157 |
| 2021 | 4 | 116 | 0 | 158 |
| 2022 | 2 | — | 0 | 148 |
| 2023 | 1 | — | 0 | 181 |
| 2024 | 0 | — | 0 | 224 |
| 2025 | 2 | — | 0 | 194 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Micrus Ascent Occlusion Balloon Catheter is intended for use in the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired and offers a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The Micrus Ascent Occlusion Balloon Catheter is also intended to assist in the delivery of diagnostic agents such as contrast media, and therapeutic agents such as occlusion coils, into the peripheral and neuro vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080861 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080861: Micrus Ascent Occlusion Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080861
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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