510(k) · Cleared
ClearedPossis Angiojet X-Stream Rheolytic Thrombectomy Catheter, Model 103587-002
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Possis Medical, Inc. · MCW Catheter, Peripheral, Atherectomy
Cleared on Apr 28, 2000 after a 190-day review. The FDA summary names its predicate without a number. 4 of the 95 devices in its family, counting itself, have a Class I recall. 94 later devices descend from it.
- Decided
- Apr 28, 2000
- Review
- 190 days
- Class
- Class II
- Product code
- MCW
- Recalls
- None
- Predicates
- 0
94 later devices descend from it, 5 citing it directly. 4 of the 95 devices in this family, counting this one, have a Class I recall.
- This deviceK993564 Possis Angiojet X-Stream Rheolytic Thrombectomy Catheter, Model…Possis Medical, Inc. · 2000
- Descendant · cites it directly · 70 of its ownK040013 Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray…Possis Medical, Inc. · 2004
- Descendant · 2 generations on · 68 of its ownK052256 Angiojet Xpeedior 120 CatheterPossis Medical, Inc. · 2005
- Descendant · cites it directly · 66 of its ownK061951 Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model Xpeedior 120Possis Medical, Inc. · 2006
- Descendant · 2 generations on · 63 of its ownK071514 Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model 104307Possis Medical, Inc. · 2007
- Descendant · cites it directly · 35 of its ownK073441 Angiojet Ultra Avx Thrombectomy Set, Model 105039Possis Medical, Inc. · 2008
Showing 5 of 94 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 94 · See all- K040013Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray Ancillary KitPossis Medical, Inc. · 2004 · cites it directly70descendants
- K052256Angiojet Xpeedior 120 CatheterPossis Medical, Inc. · 2005 · 2 generations on68descendants
- K061951Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model Xpeedior 120Possis Medical, Inc. · 2006 · cites it directly66descendants
- K071514Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model 104307Possis Medical, Inc. · 2007 · 2 generations on63descendants
- K073441Angiojet Ultra Avx Thrombectomy Set, Model 105039Possis Medical, Inc. · 2008 · cites it directly35descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993564 | Possis Angiojet X-Stream Rheolytic Thrombectomy Catheter, Model 103587-002 | Possis Medical, Inc. | 2000 | — |
| +1 | K040013 | Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray Ancillary Kit | Possis Medical, Inc. | 2004 | — |
| +2 | K052256 | Angiojet Xpeedior 120 Catheter | Possis Medical, Inc. | 2005 | — |
| +1 | K061951 | Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model Xpeedior 120 | Possis Medical, Inc. | 2006 | — |
| +2 | K071514 | Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model 104307 | Possis Medical, Inc. | 2007 | — |
| +1 | K073441 | Angiojet Ultra Avx Thrombectomy Set, Model 105039 | Possis Medical, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 6 | 0 |
| 2008 | 2 | 0 |
| 2009 | 8 | 0 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 1 |
| 2019 | 1 | 0 |
| 2020 | 5 | 0 |
| 2021 | 7 | 1 |
| 2022 | 3 | 0 |
| 2023 | 11 | 1 |
| 2024 | 3 | 0 |
| 2025 | 8 | 1 |
| 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.
4 devices in this family have 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 MCW device
- #1 K233668 Auryon Atherectomy Catheter 1.5 mm XL…score 17.6 · 18 generations · 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 |
|---|---|---|---|
| * | — | AngioJet LF140 Catheter Named without a submission number |
What descends from it? (94)
See all 945 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040013 | Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray Ancillary Kit | 2004 | 70 |
| K061951 | Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model Xpeedior 120 | 2006 | 66 |
| K073441 | Angiojet Ultra Avx Thrombectomy Set, Model 105039 | 2008 | 35 |
| K090253 | Angiojet Ultra DVX Thrombectomy Set, Model 106552-001, Angiojet Ultra Xpeedior… | 2009 | 32 |
| K012464 | Helix Hydro-Jet | 2001 | 19 |
Has anything in its family been recalled? (4 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.
- K172315Straub Endovascular SystemStraub Medical AG · 2018 · 7 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K211738Rotarex Atherectomy SystemC.R. Bard, Inc. · 2021 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc. · 2025 · 9 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
- K223210ClotTriever XL CatheterInari Medical, Inc. · 2023 · 9 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K040013 (Possis Medical, Inc., 2004) has gone furthest, with 70 descendants of its own.
How does its category compare?
All MCW devicesMCW Catheter, Peripheral, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MCW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MCW
46in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MCW
2in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · MCW
677in 2025
MAUDE reports naming product code MCW, 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 | 5 | 43 | 2 | 50 |
| 2008 | 6 | 33 | 1 | 115 |
| 2009 | 8 | 27 | 3 | 105 |
| 2010 | 6 | 30 | 1 | 167 |
| 2011 | 6 | 39 | 0 | 204 |
| 2012 | 5 | 29 | 0 | 194 |
| 2013 | 5 | 30 | 0 | 134 |
| 2014 | 7 | 117 | 0 | 210 |
| 2015 | 6 | 30 | 0 | 377 |
| 2016 | 5 | 60 | 2 | 409 |
| 2017 | 7 | 91 | 2 | 415 |
| 2018 | 8 | 103 | 0 | 537 |
| 2019 | 3 | 112 | 0 | 618 |
| 2020 | 2 | — | 0 | 631 |
| 2021 | 6 | 119 | 2 (2) | 734 |
| 2022 | 6 | 69 | 2 (2) | 566 |
| 2023 | 4 | 104 | 1 | 574 |
| 2024 | 3 | 41 | 2 | 677 |
| 2025 | 3 | 46 | 0 | 677 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The AngioJet XPEEDIOR Rheolytic™ Thrombectomy Catheter is intended for breaking apart and removing thrombus from A-V access conduits when used with the AngioJet 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/K993564 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993564: Possis Angiojet X-Stream Rheolytic Thrombectomy Catheter, Model 103587-002.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993564
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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