510(k) Report

510(k) · Cleared

Cleared

Cordis Endovascular Temporary Occlusion Balloon Catheter

K984214510(k) TraditionalCleared Aug 10, 1999259-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

Cordis Neurovascular, Inc. · DXC Clamp, Vascular

Cleared on Aug 10, 1999 after a 259-day review. The FDA summary names its predicate without a number. 31 later devices descend from it.

Decided
Aug 10, 1999
Review
259 days
Class
Class II
Product code
DXC
Recalls
None
Predicates
0

31 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared2004: 1 descendant cleared2009: 2 descendants cleared2010: 1 descendant cleared2011: 3 descendants cleared2012: 5 descendants cleared2014: 2 descendants cleared2020: 2 descendants cleared2015: 3 descendants cleared2016: 4 descendants cleared2019: 1 descendant cleared2023: 2 descendants cleared2018: 1 descendant cleared2017: 2 descendants cleared2026: 1 descendant cleared1995200020052010201520202025
  1. This deviceK984214 Cordis Endovascular Temporary Occlusion Balloon CatheterCordis Neurovascular, Inc. · 1999
  2. Descendant · cites it directly · 25 of its ownK041151 Kerberos Occluding Guide Catheter and AccessoriesKerberos Proximal Solutions, Inc. · 2004
  3. Descendant · 2 generations on · 24 of its ownK080987 Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical · 2009 · Recalled
  4. Descendant · 3 generations on · 14 of its ownK101591 Stingray Orienting Balloon CatheterBridgepoint Medical · 2010 · Recalled
  5. Descendant · 3 generations on · 11 of its ownK102725 Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter…Bridge Medical, Inc. · 2011 · Recalled
  6. Descendant · 3 generations on · 8 of its ownK121763 Multicross Support CatheterRoxwood Medical, Inc. · 2012

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

2004: 12008: 12009: 22010: 12011: 32012: 52014: 22015: 32016: 42017: 22018: 12019: 12020: 22023: 22026: 1
2004high 5 (2012) · low 0 (2005)2026

Most influential descendants

Showing 5 of 31 · See all
  • K041151Kerberos Occluding Guide Catheter and AccessoriesKerberos Proximal Solutions, Inc. · 2004 · cites it directly25descendants
  • K080987Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical · 2009 · 2 generations on24descendants
  • K101591Stingray Orienting Balloon CatheterBridgepoint Medical · 2010 · 3 generations on14descendants
  • K102725Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000…Bridge Medical, Inc. · 2011 · 3 generations on11descendants
  • K121763Multicross Support CatheterRoxwood Medical, Inc. · 2012 · 3 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K984214Cordis Endovascular Temporary Occlusion Balloon CatheterCordis Neurovascular, Inc.1999—
+1K041151Kerberos Occluding Guide Catheter and AccessoriesKerberos Proximal Solutions, Inc.2004—
+2K080987Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical20091
+3K101591Stingray Orienting Balloon CatheterBridgepoint Medical20101
+3K102725Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model…Bridge Medical, Inc.20111
+3K121763Multicross Support CatheterRoxwood Medical, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200810
200920
201010
201130
201250
201420
201530
201640
201720
201810
201910
202020
202320
202610
FIG. 1 — Lineage of K984214, 1999–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*—Prowler Infusion Catheter
Named without a submission number
—
*—NDSB Balloon Catheter
Named without a submission number
—
*—NDSB Occlusion Balloon Catheter
Named without a submission number
—
*—NDSB Balloon Catheter
Named without a submission number
—

What descends from it? (31)

See all 31

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K041151Kerberos Occluding Guide Catheter and AccessoriesKerberos Proximal Solutions, Inc.200425
K080861Micrus Ascent Occlusion Balloon CatheterMicrus Endovascular Corporation20084

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, K041151 (Kerberos Proximal Solutions, Inc., 2004) has gone furthest, with 25 descendants of its own.

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 Temporary Occlusion Balloon Catheter is intended for the temporary occlusion of blood vessels in neuro and peripheral vasculature.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Cordis Neurovascular, Inc.

37 FDA decisions under this applicant name. See the company

  • K082324Trufill DCS SyringeCordis Neurovascular, Inc. · 2008
  • K080967Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe or Trufill DCS Syringe II, Also Known as the…Cordis Neurovascular, Inc. · 2008
  • K071962Vascular Occlusion System (Trufill Pushable Coils and Trupush Coil Pusher)Cordis Neurovascular, Inc. · 2007
  • K070279Modification to Hypertransit Infusion CatheterCordis Neurovascular, Inc. · 2007
  • K063254The Trufill DCS Detachable Coil System; the Trufill DCS Orbit Detachable Coil SystemCordis Neurovascular, Inc. · 2006

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/K984214 · printed Nov 6, 2026

Cite this page

510(k) Report. “K984214: Cordis Endovascular Temporary Occlusion Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984214

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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