510(k) · Cleared
ClearedAtrium Medical Corporation Clearway Ptfe Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atrium Medical Corp. · DXE Catheter, Embolectomy
Cleared on Apr 26, 2001 after a 246-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 7 later devices descend from it.
- Decided
- Apr 26, 2001
- Review
- 246 days
- Class
- Class II
- Product code
- DXE
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK002627 Atrium Medical Corporation Clearway Ptfe Balloon CatheterAtrium Medical Corp. · 2001
- Descendant · cites it directly · 6 of its ownK080901 Lbi Embolectomy SystemLumen Biomedical, Inc. · 2008
- Descendant · 2 generations on · 5 of its ownK113757 Aspire Max Aspiration CatheterControl Medical Technology, LLC · 2012
- Descendant · 3 generations on · 1 of its ownK220780 ROVO Mechanical Thrombectomy Device2mg, Inc. · 2023
- Descendant · 3 generations on · 1 of its ownK200871 Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire…Control Medical Technology · 2020
- Descendant · 4 generations on · 0 of its ownK253730 RoVo Mechanical Thrombectomy SystemVerge Medical, Inc. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K080901Lbi Embolectomy SystemLumen Biomedical, Inc. · 2008 · cites it directly6descendants
- K113757Aspire Max Aspiration CatheterControl Medical Technology, LLC · 2012 · 2 generations on5descendants
- K220780ROVO Mechanical Thrombectomy Device2mg, Inc. · 2023 · 3 generations on1descendant
- K200871Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical AspiratorControl Medical Technology · 2020 · 3 generations on1descendant
- K253730RoVo Mechanical Thrombectomy SystemVerge Medical, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002627 | Atrium Medical Corporation Clearway Ptfe Balloon Catheter | Atrium Medical Corp. | 2001 | — |
| +1 | K080901 | Lbi Embolectomy System | Lumen Biomedical, Inc. | 2008 | — |
| +2 | K113757 | Aspire Max Aspiration Catheter | Control Medical Technology, LLC | 2012 | — |
| +3 | K220780 | ROVO Mechanical Thrombectomy Device | 2mg, Inc. | 2023 | — |
| +3 | K200871 | Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical… | Control Medical Technology | 2020 | — |
| +4 | K253730 | RoVo Mechanical Thrombectomy System | Verge Medical, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080901 | Lbi Embolectomy System | 2008 | 6 |
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, K080901 (Lumen Biomedical, Inc., 2008) has gone furthest, with 6 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 | — |
https://510kreport.com/device/K002627 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002627: Atrium Medical Corporation Clearway Ptfe 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/K002627
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026