510(k) Report

510(k) · Cleared

Recalled · 2010

Cordis Avanti Catheter Sheath Introducer

K945616510(k) TraditionalCleared Mar 29, 1995134-day reviewClass II21 CFR 870.1340Recalls 1

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 Mar 29, 1995 after a 134-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 64 later devices descend from it. It has been recalled once.

Decided
Mar 29, 1995
Review
134 days
Class
Class II
Product code
DYB
Recalls
1
Predicates
0

64 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared2013: 3 descendants cleared1996: 1 descendant cleared2008: 1 descendant cleared1998: 1 descendant cleared2012: 3 descendants cleared2005: 1 descendant cleared2016: 2 descendants cleared2007: 1 descendant cleared2015: 5 descendants cleared2010: 5 descendants cleared2009: 3 descendants cleared2014: 10 descendants cleared2011: 6 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 cleared1995200020052010201520202025
  1. This deviceK945616 Cordis Avanti Catheter Sheath IntroducerCordis Corp. · 1995
  2. Descendant · cites it directly · 44 of its ownK962746 Cordis Avanti Trans-Radial Catheter Sheath Introducer KitCordis Corp. · 1996
  3. Descendant · 2 generations on · 41 of its ownK082644 GlidesheathTerumo Medical Corp. · 2008
  4. Descendant · cites it directly · 25 of its ownK970392 Cordis Avanti+Catheter Sheath Introducer SystemCordis Corp. · 1997 · Recalled
  5. Descendant · 2 generations on · 24 of its ownK050962 Merit Prelude Sheath IntroducerMerit Medical Systems, Inc. · 2005 · Recalled
  6. Descendant · 3 generations on · 22 of its ownK070159 Prelude Sheath IntroducerMerit Medical Systems, Inc. · 2007 · Recalled

Showing 5 of 64 descendants. See all descendants

Descendants cleared per year

1996: 11997: 11998: 11999: 12005: 12007: 12008: 12009: 32010: 52011: 62012: 32013: 32014: 102015: 52016: 22017: 32018: 82019: 12022: 22023: 22024: 12025: 22026: 1
1996high 10 (2014) · low 0 (2000)2026

Most influential descendants

Showing 5 of 64 · See all
  • K962746Cordis Avanti Trans-Radial Catheter Sheath Introducer KitCordis Corp. · 1996 · cites it directly44descendants
  • K082644GlidesheathTerumo Medical Corp. · 2008 · 2 generations on41descendants
  • K970392Cordis Avanti+Catheter Sheath Introducer SystemCordis Corp. · 1997 · cites it directly25descendants
  • K050962Merit Prelude Sheath IntroducerMerit Medical Systems, Inc. · 2005 · 2 generations on24descendants
  • K070159Prelude Sheath IntroducerMerit Medical Systems, Inc. · 2007 · 3 generations on22descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K945616Cordis Avanti Catheter Sheath IntroducerCordis Corp.1995—
+1K962746Cordis Avanti Trans-Radial Catheter Sheath Introducer KitCordis Corp.1996—
+2K082644GlidesheathTerumo Medical Corp.2008—
+1K970392Cordis Avanti+Catheter Sheath Introducer SystemCordis Corp.19972
+2K050962Merit Prelude Sheath IntroducerMerit Medical Systems, Inc.20051
+3K070159Prelude Sheath IntroducerMerit Medical Systems, Inc.20073

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199710
199810
199910
200510
200710
200810
200930
201050
201160
201230
201330
2014100
201550
201620
201730
201880
201910
202220
202320
202410
202520
202610
FIG. 1 — Lineage of K945616, 1995–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DYB? 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
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (64)

See all 64

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

NumberDeviceApplicantDecidedDescendants
K962746Cordis Avanti Trans-Radial Catheter Sheath Introducer KitCordis Corp.199644
K970392Cordis Avanti+Catheter Sheath Introducer SystemCordis Corp.199725
K123618Axera 2 Access SystemArstasis, Inc.20135

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jan 28, 2010Not classifiedZ-1421-2010Package design/selectionSterility compromised: Cordis found a pin hole in one of the packaging tray cavities.On January 28, 2010 Cordis Corporation initiated a recall on their AVANTI + Introducer. During routine inspection, a visual irregularity was detected in…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K962746 (Cordis Corp., 1996) has gone furthest, with 44 descendants of its own.

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)—

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

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https://510kreport.com/device/K945616 · printed Nov 6, 2026

Cite this page

510(k) Report. “K945616: Cordis Avanti Catheter Sheath Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K945616

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026