510(k) Report

510(k) · Cleared

Cleared

Cordis Endeavor Infusion Catheter

K972110510(k) TraditionalCleared Aug 14, 199770-day reviewClass II21 CFR 870.5150

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

Cordis Corp. · QEY Mechanical Thrombolysis Catheter

Cleared on Aug 14, 1997 after a 70-day review. The FDA summary names its predicate without a number. 13 later devices descend from it.

Decided
Aug 14, 1997
Review
70 days
Class
Class II
Product code
QEY
Recalls
None
Predicates
0

13 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2008: 2 descendants cleared2011: 1 descendant cleared2019: 3 descendants cleared2021: 1 descendant cleared2024: 1 descendant cleared2020: 2 descendants cleared2026: 2 descendants cleared1995200020052010201520202025
  1. This deviceK972110 Cordis Endeavor Infusion CatheterCordis Corp. · 1997
  2. Descendant · cites it directly · 12 of its ownK063620 Ekos Micro-Infusion SystemEkos Corp. · 2007
  3. Descendant · 2 generations on · 11 of its ownK073166 Endowave Infusion SystemEkos Corp. · 2008
  4. Descendant · 3 generations on · 10 of its ownK081467 Ekosonic Endovascular System with Rapid Pulse ModulationEkos Corp. · 2008 · Recalled
  5. Descendant · 4 generations on · 9 of its ownK111705 Ekosonic Endovascular SystemEkos Corporation · 2011 · Recalled
  6. Descendant · 5 generations on · 8 of its ownK183290 Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular…Thrombolex, Inc. · 2019

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2007: 12008: 22011: 12019: 32020: 22021: 12024: 12026: 2
2007high 3 (2019) · low 0 (2009)2026

Most influential descendants

Showing 5 of 13 · See all
  • K063620Ekos Micro-Infusion SystemEkos Corp. · 2007 · cites it directly12descendants
  • K073166Endowave Infusion SystemEkos Corp. · 2008 · 2 generations on11descendants
  • K081467Ekosonic Endovascular System with Rapid Pulse ModulationEkos Corp. · 2008 · 3 generations on10descendants
  • K111705Ekosonic Endovascular SystemEkos Corporation · 2011 · 4 generations on9descendants
  • K183290Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200Thrombolex, Inc. · 2019 · 5 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K972110Cordis Endeavor Infusion CatheterCordis Corp.1997—
+1K063620Ekos Micro-Infusion SystemEkos Corp.2007—
+2K073166Endowave Infusion SystemEkos Corp.2008—
+3K081467Ekosonic Endovascular System with Rapid Pulse ModulationEkos Corp.20085
+4K111705Ekosonic Endovascular SystemEkos Corporation20115
+5K183290Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter…Thrombolex, Inc.2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200820
201110
201930
202020
202110
202410
202620
FIG. 1 — Lineage of K972110, 1997–2026Source: 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 QEY? 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 QEY device

  1. #1 K241851 Versus™ Catheter (VS110-8B)score 16.8 · 19 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*—Cordis Infusion Catheters (3.0 - 3.5 mm)
Named without a submission number
—
*—SciMed Dispatch Gold Infusion Catheters
Named without a submission number
—

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K063620Ekos Micro-Infusion SystemEkos Corp.200712

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, K063620 (Ekos Corp., 2007) has gone furthest, with 12 descendants of its own.

How does its category compare?

All QEY devices

QEY Mechanical Thrombolysis Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · QEY

1in 2024

2007: 52008: 42011: 12013: 12014: 12015: 12016: 22017: 32018: 12019: 52020: 32021: 32022: 12023: 22024: 12026 (partial year): 2
2007high 5 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QEY

62in 2021

2007: 28 days median2008: 54 days median2017: 144 days median2019: 91 days median2020: 158 days median2021: 62 days median
2007high 158 (2020) · low 28 (2007)2026

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

Recalls per year · QEY

1in 2023

2022: 12023: 1
2007high 1 (2022) · low 0 (2007)2026

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

Adverse event reports per year · QEY

5in 2025

2023: 12024: 12025: 5
2007high 5 (2025) · low 0 (2007)2025

MAUDE reports naming product code QEY, 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
200752800
200845400
20090—00
20100—00
20111—00
20120—00
20131—00
20141—00
20151—00
20162—00
2017314400
20181—00
201959100
2020315800
202136200
20221—10
20232—11
20241—01
20250—05
20262—0—

What is it indicated for?

The Cordis Endeavor Infusion Catheter is intended to deliver solutions such as heparinized saline, and thrombolytic agents, such as urokinase, to the coronary and peripheral vasculature.

Indications for use as stated in the FDA summary.

More from Cordis Corp.

551 FDA decisions under this applicant name. See the company

  • P020026/S086Cypher Sirolimus-Eluting Coronary StentCordis Corp. · 2014
  • K130981Flexstent Biliary Self Expanding Stent System; S.M.a.R.T. RE-Flex Biliary Elf-Expanding Stent SystemCordis Corp. · 2014
  • K112797Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corp. · 2012
  • P020026/S082Cypher Sirolimus-Eluting Coronary StentCordis Corp. · 2012
  • P020026/S085Cypher Sirolimus-Eluting Coronary StentCordis Corp. · 2012

Recent decisions in QEY

The QEY category page

  • K260149Versus™ Catheter (VS110-9NB)Liquet Medical, Inc. · 2026
  • K251318VariFuse Adjustable Infusion CatheterArgon Medical Devices, Inc. · 2026
  • K241851Versus™ Catheter (VS110-8B)Liquet Medical, Inc. · 2024
  • K231653BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular CatheterThrombolex, Inc. · 2023
  • K222095BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101Thrombolex, Inc. · 2023

https://510kreport.com/device/K972110 · printed Nov 4, 2026

Cite this page

510(k) Report. “K972110: Cordis Endeavor Infusion Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972110

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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