510(k) · Cleared
ClearedCatheter, Intravascular Occluding, Temporary, Model Sol 3510; Wire, Guide, Catheter, Model QSW1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Ave, Inc. · MJN Catheter, Intravascular Occluding, Temporary
Cleared on Jul 21, 2000 as substantially equivalent to K990487 (Micro Therapeutics, Inc., 1999) and 1 other predicate after a 226-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Jul 21, 2000
- Review
- 226 days
- Class
- Class II
- Product code
- MJN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K982543 (1998). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK982543 Silverstreak Hydrophilic GuidewireMicro Therapeutics, Inc. · 1998 · Recalled
- This deviceK994141 Catheter, Intravascular Occluding, Temporary, Model Sol 3510; Wire…Medtronic Ave, Inc. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K982543 | Silverstreak Hydrophilic Guidewire | Micro Therapeutics, Inc. | 1998 | 1 |
| 0 (this device) | K994141 | Catheter, Intravascular Occluding, Temporary, Model Sol 3510; Wire, Guide… | Medtronic Ave, Inc. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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? (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 |
|---|---|---|---|
| * | K990487 | Equinox Occlusion Balloon SystemSummary page 2…2 === Substantial Equivalence: The Medtronic AVE Solstice Temporary Occlusion Balloon System is substantially equivalent to the MTI, Equinox™ Occlusion Balloon System (K990487) which includes a 0.10” guide wire (SilverSpeed: K982543) Establishment of equivalence is based on similarities of intended use… | 1999 |
| * | K982543 | Silverstreak Hydrophilic GuidewireSummary page 2…e Temporary Occlusion Balloon System is substantially equivalent to the MTI, Equinox™ Occlusion Balloon System (K990487) which includes a 0.10” guide wire (SilverSpeed: K982543) Establishment of equivalence is based on similarities of intended use, design, and physical characteristics as evaluated by phy… | 1998 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 5 other devices also cite its predicate K990487.
How does its category compare?
All MJN devicesMJN Catheter, Intravascular Occluding, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Medtronic AVE Solstice™ Solstice Balloon Temporary Occlusion System is intended to be used for temporary vascular occlusion in selectively stopping or controlling blood flow in the peripheral, cerebral, and visceral 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/K994141 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994141: Catheter, Intravascular Occluding, Temporary, Model Sol 3510; Wire, Guide, Catheter, Model QSW1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994141
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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