510(k) · Cleared
ClearedBiosensors Embolectomy Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunscope Intl., Inc. · DXE Catheter, Embolectomy
Cleared on Sep 4, 1998 after a 354-day review. The FDA summary names its predicate without a number. 52 later devices descend from it.
- Decided
- Sep 4, 1998
- Review
- 354 days
- Class
- Class II
- Product code
- DXE
- Recalls
- None
- Predicates
- 0
52 later devices descend from it, 1 citing it directly.
- This deviceK973477 Biosensors Embolectomy CatheterSunscope Intl., Inc. · 1998
- Descendant · cites it directly · 51 of its ownK040010 Genesis Medical Interventional F.a.S.T. (Facilitated…Genesis Medical Interventional, Inc. · 2004
- Descendant · 2 generations on · 35 of its ownK143563 Infusion Aspiration Catheter SystemInari Medical, Inc. · 2015
- Descendant · 2 generations on · 7 of its ownK092623 F.a.S.T. System Sed and CXDGenesis Medical Interventional, Inc. · 2009
- Descendant · 3 generations on · 6 of its ownK163549 ClotTriever Thrombectomy SystemInari Medical, Inc. · 2017
- Descendant · 3 generations on · 6 of its ownK162970 FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter…Inari Medical · 2016
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 52 · See all- K040010Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction Thrombectomy)…Genesis Medical Interventional, Inc. · 2004 · cites it directly51descendants
- K143563Infusion Aspiration Catheter SystemInari Medical, Inc. · 2015 · 2 generations on35descendants
- K092623F.a.S.T. System Sed and CXDGenesis Medical Interventional, Inc. · 2009 · 2 generations on7descendants
- K163549ClotTriever Thrombectomy SystemInari Medical, Inc. · 2017 · 3 generations on6descendants
- K162970FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction AspiratorInari Medical · 2016 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973477 | Biosensors Embolectomy Catheter | Sunscope Intl., Inc. | 1998 | — |
| +1 | K040010 | Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction… | Genesis Medical Interventional, Inc. | 2004 | — |
| +2 | K143563 | Infusion Aspiration Catheter System | Inari Medical, Inc. | 2015 | — |
| +2 | K092623 | F.a.S.T. System Sed and CXD | Genesis Medical Interventional, Inc. | 2009 | — |
| +3 | K163549 | ClotTriever Thrombectomy System | Inari Medical, Inc. | 2017 | — |
| +3 | K162970 | FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction… | Inari Medical | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 8 | 0 |
| 2019 | 5 | 0 |
| 2020 | 8 | 0 |
| 2021 | 4 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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 DXE? 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 DXE device
- #1 K240078 Fogarty Thru-Lumen Embolectomy Catheterscore 7.9 · 1 generation · 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 |
|---|---|---|---|
| * | — | Baxter Healthcare’s Fogarty® Arterial Embolectomy Catheter Named without a submission number |
What descends from it? (52)
See all 521 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040010 | Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction Thrombectomy)… | 2004 | 51 |
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?
- Of its descendants, K040010 (Genesis Medical Interventional, Inc., 2004) has gone furthest, with 51 descendants of its own.
How does its category compare?
All DXE devicesDXE Catheter, Embolectomy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXE
5in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DXE
173in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXE
1in 2023
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · DXE
306in 2025
MAUDE reports naming product code DXE, 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 | 0 | — | 3 | 167 |
| 2008 | 1 | — | 0 | 134 |
| 2009 | 0 | — | 5 | 124 |
| 2010 | 2 | — | 1 | 136 |
| 2011 | 0 | — | 1 | 164 |
| 2012 | 0 | — | 0 | 200 |
| 2013 | 0 | — | 0 | 150 |
| 2014 | 0 | — | 0 | 192 |
| 2015 | 1 | — | 13 | 266 |
| 2016 | 0 | — | 0 | 796 |
| 2017 | 2 | — | 0 | 770 |
| 2018 | 0 | — | 0 | 615 |
| 2019 | 0 | — | 0 | 594 |
| 2020 | 1 | — | 0 | 547 |
| 2021 | 1 | — | 4 (4) | 333 |
| 2022 | 1 | — | 3 | 463 |
| 2023 | 0 | — | 1 | 436 |
| 2024 | 5 | 173 | 0 | 377 |
| 2025 | 0 | — | 0 | 306 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The Biosensors Embolectomy Catheter is indicated for use in the removal of
emboli and thrombi from the arterial system. The catheter should be used only by
a physician with surgical skill in the vascular system.
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/K973477 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973477: Biosensors Embolectomy Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973477
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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