510(k) · Cleared
ClearedPossis Angiojet Rapid Thrombectomy Catheter System, F105 Catheter,Model 3030C,LF140 Catheter,Model 3040C,Pump Set 3020P
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 Dec 3, 1996 as substantially equivalent to K901627 (Applied Vascular Devices, Inc., 1990) after a 267-day review. Its family tree reaches back 1 generation to 1990. 4 of the 89 devices in its family, counting itself, have a Class I recall. 87 later devices descend from it.
- Decided
- Dec 3, 1996
- Review
- 267 days
- Class
- Class II
- Product code
- MCW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K901627 (1990). 87 later devices descend from it, 7 citing it directly. 4 of the 89 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK901627 Arterial Embolectomy CatheterApplied Vascular Devices, Inc. · 1990 · Recalled
- This deviceK960970 Possis Angiojet Rapid Thrombectomy Catheter System, F105…Possis Medical, Inc. · 1996
- Descendant · cites it directly · 81 of its ownK972610 Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model…Possis Medical, Inc. · 2000
- Descendant · 2 generations on · 70 of its ownK040013 Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray…Possis Medical, Inc. · 2004
- Descendant · 3 generations on · 68 of its ownK052256 Angiojet Xpeedior 120 CatheterPossis Medical, Inc. · 2005
- Descendant · 3 generations on · 66 of its ownK061951 Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model Xpeedior 120Possis Medical, Inc. · 2006
- Descendant · 3 generations on · 63 of its ownK071514 Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model 104307Possis Medical, Inc. · 2007
Showing 5 of 87 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 87 · See all- K972610Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model 3030C, LF140 Catheter…Possis Medical, Inc. · 2000 · cites it directly81descendants
- K040013Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray Ancillary KitPossis Medical, Inc. · 2004 · 2 generations on70descendants
- K052256Angiojet Xpeedior 120 CatheterPossis Medical, Inc. · 2005 · 3 generations on68descendants
- K061951Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model Xpeedior 120Possis Medical, Inc. · 2006 · 3 generations on66descendants
- K071514Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model 104307Possis Medical, Inc. · 2007 · 3 generations on63descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K901627 | Arterial Embolectomy Catheter | Applied Vascular Devices, Inc. | 1990 | 1 |
| 0 (this device) | K960970 | Possis Angiojet Rapid Thrombectomy Catheter System, F105 Catheter,Model… | Possis Medical, Inc. | 1996 | — |
| +1 | K972610 | Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model 3030C, LF140… | Possis Medical, Inc. | 2000 | — |
| +2 | K040013 | Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray Ancillary Kit | Possis Medical, Inc. | 2004 | — |
| +3 | K052256 | Angiojet Xpeedior 120 Catheter | Possis Medical, Inc. | 2005 | — |
| +3 | K061951 | Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model Xpeedior 120 | Possis Medical, Inc. | 2006 | — |
| +3 | K071514 | Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model 104307 | Possis Medical, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 6 | 0 |
| 2008 | 3 | 0 |
| 2009 | 7 | 0 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 6 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 1 |
| 2020 | 2 | 0 |
| 2021 | 6 | 1 |
| 2022 | 2 | 0 |
| 2023 | 9 | 1 |
| 2024 | 3 | 0 |
| 2025 | 5 | 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? (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 |
|---|---|---|---|
| * | K901627 | Arterial Embolectomy CatheterSummary page 1…3000A Embolectomy Catheter Thrombectomy Catheter Embolectomy Catheter (21 CFR 870.5150) Applied Vascular Arterial Embolectomy Catheter Applied Vascular Devices, Inc. K901627 Fogarty® Arterial Embolectomy Catheter Baxter Healthcare Corp., Edwards U.S. Division (pre-1976 device) 11/22/9… | 1990 |
| * | — | Fogarty® Arterial Embolectomy Catheter Named without a submission number |
What descends from it? (87)
See all 877 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K972610 | Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model 3030C, LF140 Catheter… | 2000 | 81 |
| K073441 | Angiojet Ultra Avx Thrombectomy Set, Model 105039 | 2008 | 35 |
| K090253 | Angiojet Ultra DVX Thrombectomy Set, Model 106552-001, Angiojet Ultra Xpeedior… | 2009 | 32 |
| K021096 | X-Sizer Catheter System | 2004 | 6 |
| K072769 | Angiojet Ultra; Xmi (105041), XVG (105042) and Spiroflex (106553) Thrombectomy Sets | 2007 | 1 |
| K013473 | XTD Thrombectomy Catheter, XX CM, Model# CT000500X; XTD Control Console, Model #… | 2002 | 1 |
| K080806 | Angiojet Ultra Spiroflex VG Thrombectomy Set, Model 106608 | 2008 | 0 |
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 · 8 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K211738Rotarex Atherectomy SystemC.R. Bard, Inc. · 2021 · 9 generations on · ◆ in the 2021 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
- K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc. · 2025 · 10 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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 Possis AngioJet Rapid Thrombectomy System is intended for breaking apart and removing unorganized thrombus from A-V access grafts.
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/K960970 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960970: Possis Angiojet Rapid Thrombectomy Catheter System, F105 Catheter,Model 3030C,LF140 Catheter,Model 3040C,Pump Set 3020P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960970
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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