510(k) Report

510(k) · Cleared

Cleared

Cordis Avanti Trans-Radial Catheter Sheath Introducer Kit

K962746510(k) TraditionalCleared Oct 11, 199688-day reviewClass II21 CFR 870.1340

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

Cordis Corp. · DYB Introducer, Catheter

Cleared on Oct 11, 1996 as substantially equivalent to K945616 (Cordis Corp., 1995) and 3 other predicates after an 88-day review. Its family tree reaches back 1 generation to 1981. 1 of the 49 devices in its family, counting itself, has a Class I recall. 44 later devices descend from it.

Decided
Oct 11, 1996
Review
88 days
Class
Class II
Product code
DYB
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K810675 (1981). 4 ancestors in all. 44 later devices descend from it, 3 citing it directly. 1 of the 49 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor1993: 1 other ancestor1991: 1 other ancestor2008: 1 descendant cleared1998: 1 descendant cleared2012: 2 descendants cleared2015: 4 descendants cleared2010: 1 descendant cleared2009: 3 descendants cleared2016: 1 descendant cleared2014: 7 descendants cleared2011: 3 descendants cleared1999: 1 descendant cleared2017: 3 descendants cleared2025: 2 descendants cleared2018: 8 descendants cleared2024: 1 descendant cleared2022: 2 descendants cleared2023: 2 descendants cleared2019: 1 descendant cleared2026: 1 descendant clearedK810675 · Arrow Radial Artery Catheterization Set · Arrow Intl., Inc. · 1981 · Class I recall19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 3 descendants2 generations forward: 10 descendants3 generations forward: 8 descendants4 generations forward: 12 descendants5 generations forward: 8 descendants6 generations forward: 2 descendants7 generations forward: 1 descendant K810675 · Arrow Radial Artery Catheterization Set · Arrow Intl., Inc. · 1981 · Class I recall0+5
  1. Root · 1 generation backK810675 Arrow Radial Artery Catheterization SetArrow Intl., Inc. · 1981 · Recalled (Class I)
  2. This deviceK962746 Cordis Avanti Trans-Radial Catheter Sheath Introducer KitCordis Corp. · 1996
  3. Descendant · cites it directly · 41 of its ownK082644 GlidesheathTerumo Medical Corp. · 2008
  4. Descendant · 2 generations on · 17 of its ownK102008 GlidesheathTerumo Medical Corp. · 2010 · Recalled
  5. Descendant · 2 generations on · 12 of its ownK122980 Glidesheath Slender Model RM* ES6J10HQS, Glidesheath Slender Model…Terumo Medical Corporation · 2012
  6. Descendant · 3 generations on · 8 of its ownK142183 Glidesheath SlenderTerumo Medical Corporation · 2014 · Recalled
  7. Descendant · 3 generations on · 7 of its ownK111606 Pinnacle Precision Access SystemTerumo Medical Corp. · 2011 · Recalled

Showing 5 of 44 descendants. See all descendants

Descendants cleared per year

1998: 11999: 12008: 12009: 32010: 12011: 32012: 22014: 72015: 42016: 12017: 32018: 82019: 12022: 22023: 22024: 12025: 22026: 1
1998high 8 (2018) · low 0 (2000)2026

Class I recalls in this family

  • K810675 Arrow Radial Artery Catheterization Setdirect predicate · 1981

Most influential descendants

Showing 5 of 44 · See all
  • K082644GlidesheathTerumo Medical Corp. · 2008 · cites it directly41descendants
  • K102008GlidesheathTerumo Medical Corp. · 2010 · 2 generations on17descendants
  • K122980Glidesheath Slender Model RM* ES6J10HQS, Glidesheath Slender Model RM* ES6F16HQ…Terumo Medical Corporation · 2012 · 2 generations on12descendants
  • K142183Glidesheath SlenderTerumo Medical Corporation · 2014 · 3 generations on8descendants
  • K111606Pinnacle Precision Access SystemTerumo Medical Corp. · 2011 · 3 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K810675Arrow Radial Artery Catheterization SetArrow Intl., Inc.1981Class I
0 (this device)K962746Cordis Avanti Trans-Radial Catheter Sheath Introducer KitCordis Corp.1996—
+1K082644GlidesheathTerumo Medical Corp.2008—
+2K102008GlidesheathTerumo Medical Corp.20101
+2K122980Glidesheath Slender Model RM* ES6J10HQS, Glidesheath Slender Model RM*…Terumo Medical Corporation2012—
+3K142183Glidesheath SlenderTerumo Medical Corporation201417
+3K111606Pinnacle Precision Access SystemTerumo Medical Corp.20111

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199310
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199910
200810
200930
201010
201130
201220
201470
201540
201610
201730
201880
201910
202220
202320
202410
202520
202610
FIG. 1 — Lineage of K962746, 1981–2026Source: 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.

1 device in this family has a Class I recall. 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 DYB device

  1. #1 K251051 AuST Steerable Sheathscore 18.0 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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
*K945616Cordis Avanti Catheter Sheath Introducer
Summary page 1
…Sheath Introducer Kit Applicant Name and Address: Cordis P.O. Box 025700 Miami, FL 33015-5700 II. Name of Predicate Devices Cordis Avanti™ Catheter Sheath Introducer K945616 and K932733 Cordis Plus Catheter Sheath Introducer K911794 Arrow Radial Artery Catheterization Set K810675 II1. Classification…
Cordis Corp.19951
*K932733Cordis Catheter Sheath Introducer
Summary page 1
…ducer Kit Applicant Name and Address: Cordis P.O. Box 025700 Miami, FL 33015-5700 II. Name of Predicate Devices Cordis Avanti™ Catheter Sheath Introducer K945616 and K932733 Cordis Plus Catheter Sheath Introducer K911794 Arrow Radial Artery Catheterization Set K810675 II1. Classification Catheter She…
Cordis Corp.1993—
*K911794Cath Sheath Introducer Syst Plus W/Unistasis Valve
Summary page 1
…P.O. Box 025700 Miami, FL 33015-5700 II. Name of Predicate Devices Cordis Avanti™ Catheter Sheath Introducer K945616 and K932733 Cordis Plus Catheter Sheath Introducer K911794 Arrow Radial Artery Catheterization Set K810675 II1. Classification Catheter Sheath Introducer Kits are Cardiovascular Diagnost…
Cordis Corp.1991—
*K810675Arrow Radial Artery Catheterization Set
Summary page 1
…f Predicate Devices Cordis Avanti™ Catheter Sheath Introducer K945616 and K932733 Cordis Plus Catheter Sheath Introducer K911794 Arrow Radial Artery Catheterization Set K810675 II1. Classification Catheter Sheath Introducer Kits are Cardiovascular Diagnostic Devices and are classified as Class II device…
Arrow Intl., Inc.1981Class I

Also cleared against K945616: 2 other devices →

What descends from it? (44)

See all 44

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

NumberDeviceApplicantDecidedDescendants
K082644GlidesheathTerumo Medical Corp.200841
K110051Radialsource Transradial Access Introducer KitGreat Batch Medical20123
K980504Emcee Introducer Sheath, Dilator, Obturator, Introducer SetSchneider/Namic19981

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K810675Arrow Radial Artery Catheterization SetArrow Intl., Inc. · 1981 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

  • 2 of the 4 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K082644 (Terumo Medical Corp., 2008) has gone furthest, with 41 descendants of its own.
  • 2 other devices also cite its predicate K945616.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DYB

16in 2025

2007: 122008: 172009: 142010: 182011: 172012: 222013: 262014: 302015: 172016: 192017: 242018: 192019: 182020: 92021: 122022: 132023: 152024: 182025: 162026 (partial year): 17
2007high 30 (2014) · low 9 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DYB

63in 2025

2007: 95 days median2008: 37 days median2009: 52 days median2010: 123 days median2011: 100 days median2012: 128 days median2013: 118 days median2014: 122 days median2015: 129 days median2016: 95 days median2017: 70 days median2018: 156 days median2019: 47 days median2020: 49 days median2021: 78 days median2022: 143 days median2023: 55 days median2024: 56 days median2025: 63 days median2026 (partial year): 59 days median
2007high 156 (2018) · low 37 (2008)2026

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

Recalls per year · DYB

3in 2025

2007: 152008: 92009: 252010: 182011: 42012: 32013: 5, 1 Class I2014: 22015: 2, 1 Class I2016: 45, 3 Class I2017: 22, 1 Class I2018: 12019: 22020: 21, 21 Class I2021: 62022: 22023: 102024: 22025: 32026 (partial year): 23, 21 Class I
2007high 45 (2016) · low 1 (2018)2026

Class I (48 since 2007) Class II/III not classified

Adverse event reports per year · DYB

4,539in 2025

2007: 3162008: 4232009: 3992010: 4452011: 6282012: 8982013: 7432014: 7802015: 9132016: 1,2342017: 1,6722018: 1,9032019: 2,4502020: 2,4652021: 2,8352022: 4,0842023: 3,7752024: 3,9312025: 4,539
2007high 4,539 (2025) · low 316 (2007)2025

MAUDE reports naming product code DYB, 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
2007129515316
200817379423
2009145225399
20101812318445
2011171004628
2012221283898
2013261185 (1)743
2014301222780
2015171292 (1)913
2016199545 (3)1,234
2017247022 (1)1,672
20181915611,903
2019184722,450
202094921 (21)2,465
2021127862,835
20221314324,084
20231555103,775
2024185623,931
2025166334,539
2026175923 (21)—

What is it indicated for?

The Avanti™ Trans-Radial Catheter Sheath Introducer kit is intended for use in (radial) arterial procedures requiring percutaneous introduction of catheters and other intravascular devices. As with other currently marketed Cordis CSIs mentioned in this submission, these devices provide vascular access for various intravascular devices through the valve while simuitaneously maintaining hemostasis. Infusion of fluids into the vasculature and withdrawal of blood from the vasculature are possible using the sheath sideport.

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

Also cleared against K945616

2 other devices cite the same predicate.

  • K123618Axera 2 Access SystemArstasis, Inc. · 2013
  • K970392Cordis Avanti+Catheter Sheath Introducer SystemCordis Corp. · 19972 recalls

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 DYB

The DYB category page

  • K262674Giranel Guiding Sheath SetKossel Medtech (Suzhou) Co., Ltd. · 2026
  • K253526NAMIC Dilator and SheathMedline Industries, LP · 2026
  • K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit /…Hartman Medical Group, LLC · 2026
  • K261242SimplGuidePendracare · 2026
  • K261950Health Line Tearaway IntroducerHealth Line International Corporation · 2026

https://510kreport.com/device/K962746 · printed Nov 4, 2026

Cite this page

510(k) Report. “K962746: Cordis Avanti Trans-Radial Catheter Sheath Introducer Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962746

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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