510(k) · Cleared
ClearedVasostasis Vascular Closure System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiva Medical, Inc. · DXC Clamp, Vascular
Cleared on Oct 22, 2004 after a 140-day review. The FDA summary names its predicate without a number. 19 later devices descend from it.
- Decided
- Oct 22, 2004
- Review
- 140 days
- Class
- Class II
- Product code
- DXC
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 3 citing it directly.
- This deviceK041486 Vasostasis Vascular Closure SystemCardiva Medical, Inc. · 2004
- Descendant · cites it directly · 13 of its ownK061075 Boomerang WireCardiva Medical, Inc. · 2006
- Descendant · cites it directly · 12 of its ownK091006 Itg Vascular Access System, Model 300Arstasis, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 11 of its ownK100615 Arstasis Access SystemArstasis, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 10 of its ownK102728 Arstasis Access SystemArstasis, Inc. · 2010 · Recalled
- Descendant · 4 generations on · 9 of its ownK103143 Arstasis One Latchwire Access SystemArstasis, Inc. · 2011
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K061075Boomerang WireCardiva Medical, Inc. · 2006 · cites it directly13descendants
- K091006Itg Vascular Access System, Model 300Arstasis, Inc. · 2010 · cites it directly12descendants
- K100615Arstasis Access SystemArstasis, Inc. · 2010 · 2 generations on11descendants
- K102728Arstasis Access SystemArstasis, Inc. · 2010 · 3 generations on10descendants
- K103143Arstasis One Latchwire Access SystemArstasis, Inc. · 2011 · 4 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041486 | Vasostasis Vascular Closure System | Cardiva Medical, Inc. | 2004 | — |
| +1 | K061075 | Boomerang Wire | Cardiva Medical, Inc. | 2006 | — |
| +1 | K091006 | Itg Vascular Access System, Model 300 | Arstasis, Inc. | 2010 | 1 |
| +2 | K100615 | Arstasis Access System | Arstasis, Inc. | 2010 | 1 |
| +3 | K102728 | Arstasis Access System | Arstasis, Inc. | 2010 | 1 |
| +4 | K103143 | Arstasis One Latchwire Access System | Arstasis, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 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 DXC? 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 DXC device
- #1 K262086 PreludeSYNC™ Radial Compression Devicescore 13.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | — | FemoStop™ System Named without a submission number | |
| * | — | COMPRESSAR® Universal System Named without a submission number | |
| * | — | CTS FloCoil™ Shunt Named without a submission number | |
| * | — | Flo-Rester® Internal Vessel Occluder Named without a submission number |
What descends from it? (19)
See all 193 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K061075 (Cardiva Medical, Inc., 2006) has gone furthest, with 13 descendants of its own.
How does its category compare?
All DXC devicesDXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXC
215in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXC
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXC
442in 2025
MAUDE reports naming product code DXC, 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 | 10 | 52 | 0 | 298 |
| 2008 | 3 | 29 | 2 | 302 |
| 2009 | 4 | 83 | 2 | 539 |
| 2010 | 2 | — | 1 | 600 |
| 2011 | 6 | 51 | 3 | 691 |
| 2012 | 5 | 73 | 0 | 548 |
| 2013 | 14 | 89 | 0 | 920 |
| 2014 | 4 | 157 | 1 | 494 |
| 2015 | 5 | 71 | 0 | 374 |
| 2016 | 3 | 91 | 0 | 494 |
| 2017 | 3 | 90 | 0 | 416 |
| 2018 | 2 | — | 0 | 391 |
| 2019 | 2 | — | 0 | 393 |
| 2020 | 3 | 209 | 0 | 404 |
| 2021 | 6 | 37 | 0 | 371 |
| 2022 | 1 | — | 1 | 273 |
| 2023 | 4 | 215 | 2 | 674 |
| 2024 | 1 | — | 0 | 375 |
| 2025 | 2 | — | 0 | 442 |
| 2026 | 4 | 125 | 0 | — |
What is it indicated for?
The Cardiva Medical VasoStasis TM Vascular Closure System is intended to promote
hemostasis at arteriotomy sites as an adjunct to manual compression. The VasoStasis
Vascular Closure System is indicated for use in patients undergoing diagnostic femoral
artery catheterization procedures, using 5 or 6 Fr introducer sheaths.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041486 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041486: Vasostasis Vascular Closure System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041486
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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