510(k) Report

510(k) · Cleared

Cleared

Boomerang Closurewire Vascular Closure System

K051817510(k) TraditionalCleared Dec 6, 2006519-day reviewClass II21 CFR 870.4450

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cardiva Medical, Inc. · DXC Clamp, Vascular

Cleared on Dec 6, 2006 as substantially equivalent to K041486 (Cardiva Medical, Inc., 2004) and 2 other predicates after a 519-day review. Its family tree reaches back 1 generation to 1992. 4 later devices descend from it.

Decided
Dec 6, 2006
Review
519 days
Class
Class II
Product code
DXC
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K915280 (1992). 3 ancestors in all. 4 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor1997: 1 other ancestor2007: 2 descendants cleared2013: 1 descendant cleared2009: 1 descendant clearedK915280 · Femostop · Radi Medical Systems AB · 19921990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 1 descendant K915280 · Femostop · Radi Medical Systems AB · 19920
  1. Root · 1 generation backK915280 FemostopRadi Medical Systems AB · 1992
  2. This deviceK051817 Boomerang Closurewire Vascular Closure SystemCardiva Medical, Inc. · 2006
  3. Descendant · cites it directly · 3 of its ownK070485 Boomerang Wire /Boomerang Plus Wire System, Model# B Plus Wire 58LCardiva Medical, Inc. · 2007
  4. Descendant · 2 generations on · 2 of its ownK072297 Boomerang Catalyst/Boomerang Catalyst II SystemCardiva Medical, Inc. · 2007
  5. Descendant · 3 generations on · 1 of its ownK082930 Cardiva Catalyst Iii System with Protamine SulfateCardiva Medical, Inc. · 2009
  6. Descendant · 2 generations on · 0 of its ownK130124 Catalyst II and IiiCardiva Medical, Inc. · 2013

Most influential descendants

Showing 4 of 4 · See all
  • K070485Boomerang Wire /Boomerang Plus Wire System, Model# B Plus Wire 58LCardiva Medical, Inc. · 2007 · cites it directly3descendants
  • K072297Boomerang Catalyst/Boomerang Catalyst II SystemCardiva Medical, Inc. · 2007 · 2 generations on2descendants
  • K082930Cardiva Catalyst Iii System with Protamine SulfateCardiva Medical, Inc. · 2009 · 3 generations on1descendant
  • K130124Catalyst II and IiiCardiva Medical, Inc. · 2013 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K915280FemostopRadi Medical Systems AB1992—
0 (this device)K051817Boomerang Closurewire Vascular Closure SystemCardiva Medical, Inc.2006—
+1K070485Boomerang Wire /Boomerang Plus Wire System, Model# B Plus Wire 58LCardiva Medical, Inc.2007—
+2K072297Boomerang Catalyst/Boomerang Catalyst II SystemCardiva Medical, Inc.2007—
+3K082930Cardiva Catalyst Iii System with Protamine SulfateCardiva Medical, Inc.2009—
+2K130124Catalyst II and IiiCardiva Medical, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200720
200910
201310
FIG. 1 — Lineage of K051817, 1992–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K262086 PreludeSYNC™ Radial Compression Devicescore 13.5 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K041486Vasostasis Vascular Closure System
Summary page 1
…Blood Access Device and Accessories (21 CRF §870.5540) Classification: Class I1 PREDICATE DEVICES Cardiva Medical VasoStasis Vascular Closure System (K041486) Radi Medical Systems AB, FemoStopTM System (K915280) CardioThoracic Systems, Inc., CTS FloCoilTM Shunt (K970638) INTENDED USE/I…
Cardiva Medical, Inc.2004—
*K915280Femostop
Summary page 1
…540) Classification: Class I1 PREDICATE DEVICES Cardiva Medical VasoStasis Vascular Closure System (K041486) Radi Medical Systems AB, FemoStopTM System (K915280) CardioThoracic Systems, Inc., CTS FloCoilTM Shunt (K970638) INTENDED USE/INDICATIONS FOR USE The Cardiva Medical Boomerang TM…
Radi Medical Systems AB1992—
*K970638CTS Midcab Fixedn Diameter Coronary Shunt
Summary page 1
…CES Cardiva Medical VasoStasis Vascular Closure System (K041486) Radi Medical Systems AB, FemoStopTM System (K915280) CardioThoracic Systems, Inc., CTS FloCoilTM Shunt (K970638) INTENDED USE/INDICATIONS FOR USE The Cardiva Medical Boomerang TM Wire System is intended to promote hemostasis at arteriotomy…
Cardiothoracic Systems, Inc.1997—

Also cleared against K041486: 2 other devices →

What descends from it? (4)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K070485Boomerang Wire /Boomerang Plus Wire System, Model# B Plus Wire 58LCardiva Medical, Inc.20073

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K070485 (Cardiva Medical, Inc., 2007) has gone furthest, with 3 descendants of its own.
  • 2 other devices also cite its predicate K041486.

How does its category compare?

All DXC devices

DXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DXC

2in 2025

2007: 102008: 32009: 42010: 22011: 62012: 52013: 142014: 42015: 52016: 32017: 32018: 22019: 22020: 32021: 62022: 12023: 42024: 12025: 22026 (partial year): 4
2007high 14 (2013) · low 1 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXC

215in 2023

2007: 52 days median2008: 29 days median2009: 83 days median2011: 51 days median2012: 73 days median2013: 89 days median2014: 157 days median2015: 71 days median2016: 91 days median2017: 90 days median2020: 209 days median2021: 37 days median2023: 215 days median2026 (partial year): 125 days median
2007high 215 (2023) · low 29 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DXC

2in 2023

2008: 22009: 22010: 12011: 32014: 12022: 12023: 2
2007high 3 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DXC

442in 2025

2007: 2982008: 3022009: 5392010: 6002011: 6912012: 5482013: 9202014: 4942015: 3742016: 4942017: 4162018: 3912019: 3932020: 4042021: 3712022: 2732023: 6742024: 3752025: 442
2007high 920 (2013) · low 273 (2022)2025

MAUDE reports naming product code DXC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200710520298
20083292302
20094832539
20102—1600
20116513691
20125730548
201314890920
201441571494
20155710374
20163910494
20173900416
20182—0391
20192—0393
202032090404
20216370371
20221—1273
202342152674
20241—0375
20252—0442
202641250—

What is it indicated for?

The Boomerang TM Wire System is intended to promote hemostasis at an arteriotomy site as an adjunct to manual compression. The Boomerang TM Wire System is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures using 5, 6 or 7 Fr introducer sheaths.

Indications for use as stated in the FDA summary.

Also cleared against K041486

2 other devices cite the same predicate.

  • K091006Itg Vascular Access System, Model 300Arstasis, Inc. · 20101 recall
  • K061075Boomerang WireCardiva Medical, Inc. · 2006

More from Cardiva Medical, Inc.

51 FDA decisions under this applicant name. See the company

  • P120016/S043VASCADE 5F Vascular Closure SystemCardiva Medical, Inc. · 2026
  • P120016/S040Cardiva, VASCADE FamilyCardiva Medical, Inc. · 2026
  • P120016/S039VASCADE MVP XL VVCS Model 800-1014XLCardiva Medical, Inc. · 2026
  • P120016/S038Vascular Closure System (VCS)-VASCADE 5F Vascular Closure System, VASCADE 6/7F Vascular Closure System…Cardiva Medical, Inc. · 2025
  • P120016/S037Cardiva VASCADE MVP XL Venous Vascular Closure System (VVCS)Cardiva Medical, Inc. · 2024

Recent decisions in DXC

The DXC category page

  • K262086PreludeSYNC™ Radial Compression DeviceMerit Medical Systems, Inc. · 2026
  • K260105Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsEdwards Lifesciences · 2026
  • K252772Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc. · 2026
  • K254060Life Saving TourniquetTW Medical · 2026
  • K243627Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)Arc Trauma, LLC · 2025

https://510kreport.com/device/K051817 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051817: Boomerang Closurewire 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/K051817

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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