510(k) · Cleared
ClearedCardiva Catalyst Iii System with Protamine Sulfate
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 Feb 13, 2009 as substantially equivalent to K072297 (Cardiva Medical, Inc., 2007) after a 135-day review. Its family tree reaches back 4 generations to 1992. 1 later device descends from it.
- Decided
- Feb 13, 2009
- Review
- 135 days
- Class
- Class II
- Product code
- DXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K915280 (1992). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK915280 FemostopRadi Medical Systems AB · 1992
- 3 generations backK051817 Boomerang Closurewire Vascular Closure SystemCardiva Medical, Inc. · 2006
- 2 generations backK070485 Boomerang Wire /Boomerang Plus Wire System, Model# B Plus Wire 58LCardiva Medical, Inc. · 2007
- 1 generation backK072297 Boomerang Catalyst/Boomerang Catalyst II SystemCardiva Medical, Inc. · 2007
- This deviceK082930 Cardiva Catalyst Iii System with Protamine SulfateCardiva Medical, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK130124 Catalyst II and IiiCardiva Medical, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K130124Catalyst II and IiiCardiva Medical, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K915280 | Femostop | Radi Medical Systems AB | 1992 | — |
| −3 | K051817 | Boomerang Closurewire Vascular Closure System | Cardiva Medical, Inc. | 2006 | — |
| −2 | K070485 | Boomerang Wire /Boomerang Plus Wire System, Model# B Plus Wire 58L | Cardiva Medical, Inc. | 2007 | — |
| −1 | K072297 | Boomerang Catalyst/Boomerang Catalyst II System | Cardiva Medical, Inc. | 2007 | — |
| 0 (this device) | K082930 | Cardiva Catalyst Iii System with Protamine Sulfate | Cardiva Medical, Inc. | 2009 | — |
| +1 | K130124 | Catalyst II and Iii | Cardiva Medical, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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? (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 |
|---|---|---|---|
| * | K072297 | Boomerang Catalyst/Boomerang Catalyst II SystemSummary page 1…s II Product Code: DXC Trade Name: Cardiva CatalystTM III System Generic/Common Name: Vascular Clamp PREDICATE DEVICE Cardiva Medical BoomerangTM Catalyst II System (K072297) INTENDED USE The Cardiva CatalystTM III System with Protamine Sulfate is intended.to promote hemostasis at arteriotomy sites as… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130124 | Catalyst II and Iii | 2013 | 0 |
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?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K130124 (Cardiva Medical, Inc., 2013) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K072297.
How does its category compare?
All DXC devicesDXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 CatalystTM III System with Protamine Sulfate is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression in heparinized patients. The Cardiva CatalystTM III System is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures using 5F, 6F or 7F introducer sheaths.
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/K082930 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082930: Cardiva Catalyst Iii System with Protamine Sulfate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082930
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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