510(k) · Cleared

Recalled · 2003

Cordis Brite Tip Catheter Sheath Introducer System

K984500510(k) SpecialCleared Dec 23, 19986-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 Dec 23, 1998 after a 6-day review. The FDA summary names its predicate without a number. 4 of the 27 devices in its family, counting itself, have a Class I recall. 26 later devices descend from it. It has been recalled once.

Decided: Dec 23, 1998
Review: 6 days
Class: Class II
Product code: DYB
Recalls: 1
Predicates: 0

26 later devices descend from it, 4 citing it directly. 4 of the 27 devices in this family, counting this one, have a Class I recall.

This deviceK984500 Cordis Brite Tip Catheter Sheath Introducer SystemCordis Corp. · 1998
Descendant · cites it directly · 13 of its ownK142829 Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor…Cook Incorporated · 2015 · Recalled (Class I)
Descendant · 2 generations on · 6 of its ownK152913 GORE TIPS Set, GORE TIPS Sheath, GORE TIPS NeedleCreganna Medical Aslo Business AS Cregganna Tactx Medical · 2016 · Recalled
Descendant · cites it directly · 6 of its ownK020316 Cordis Trapease Permanent Vena Cava Filter with the Visease…Cordis Corp. · 2002
Descendant · 3 generations on · 5 of its ownK171820 Transjugular Liver Access SetsCook Incorporated · 2018 · Recalled
Descendant · 2 generations on · 5 of its ownK034050 Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B…Cordis Corporation · 2004 · Recalled (Class I)

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2002high 4 (2016) · low 0 (2003)2026

Class I recalls in this family

K161183 Halo One Thin-Walled Guiding Sheathcites it directly · 2016
K142829 Flexor Tuohy-Borst Side-Arm Introducer, Ansel…cites it directly · 2015
K034050 Cordis Optease Vena Cava Filter, Models…2 generations on · 2004
K091077 Optease Vena Cava Filter and Retrieval Catheter3 generations on · 2010

Most influential descendants

Showing 5 of 26 · See all

K142829Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer…Cook Incorporated · 2015 · cites it directly13descendants
K152913GORE TIPS Set, GORE TIPS Sheath, GORE TIPS NeedleCreganna Medical Aslo Business AS Cregganna Tactx Medical · 2016 · 2 generations on6descendants
K020316Cordis Trapease Permanent Vena Cava Filter with the Visease Angiographic Vessel Dilator…Cordis Corp. · 2002 · cites it directly6descendants
K171820Transjugular Liver Access SetsCook Incorporated · 2018 · 3 generations on5descendants
K034050Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable Catheter…Cordis Corporation · 2004 · 2 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K984500	Cordis Brite Tip Catheter Sheath Introducer System	Cordis Corp.	1998	—
+1	K142829	Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo…	Cook Incorporated	2015	Class I
+2	K152913	GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle	Creganna Medical Aslo Business AS Cregganna Tactx Medical	2016	1
+1	K020316	Cordis Trapease Permanent Vena Cava Filter with the Visease Angiographic…	Cordis Corp.	2002	—
+3	K171820	Transjugular Liver Access Sets	Cook Incorporated	2018	2
+2	K034050	Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable…	Cordis Corporation	2004	Class I

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2004	1	1
2010	1	1
2014	1	0
2015	3	1
2016	4	1
2017	1	0
2018	3	0
2019	1	0
2020	2	0
2021	4	0
2022	1	0
2023	1	0
2025	2	0

FIG. 1 — Lineage of K984500, 1998–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

4 devices in this family have 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 K251051 AuST Steerable Sheathscore 18.0 · 10 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	—	Brite Tip Catheter Sheath Introducers Named without a submission number			—

What descends from it? (26)

See all 26

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

Number	Device	Applicant	Decided	Descendants
K142829	Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer… Class I	Cook Incorporated	2015	13
K020316	Cordis Trapease Permanent Vena Cava Filter with the Visease Angiographic Vessel Dilator…	Cordis Corp.	2002	6
K161183	Halo One Thin-Walled Guiding Sheath Class I	C.R. Bard, Inc.	2016	2
K142819	Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set	Cook Incorporated	2015	1

Has anything in its family been recalled? (4 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 5, 2003	Not classified	Z-0941-03	Other	Reports of broken or separated tips of the catheter sheath introducers.

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.

K161183Halo One Thin-Walled Guiding SheathC.R. Bard, Inc. · 2016 · Cites it directly · ◆ in the 2016 descendants bar of FIG. 13 Class I recalls
K142829Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification…Cook Incorporated · 2015 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 121 Class I recalls
K034050Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable Catheter, Model 466-C220FCordis Corporation · 2004 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
K091077Optease Vena Cava Filter and Retrieval CatheterCordis Corp., A Johnson & Johnson Co. · 2010 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K142829 (Cook Incorporated, 2015) has gone furthest, with 13 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

2007high 30 (2014) · low 9 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DYB

63in 2025

2007high 156 (2018) · low 37 (2008)2026

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

Recalls per year · DYB

3in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	12	95	15	316
2008	17	37	9	423
2009	14	52	25	399
2010	18	123	18	445
2011	17	100	4	628
2012	22	128	3	898
2013	26	118	5 (1)	743
2014	30	122	2	780
2015	17	129	2 (1)	913
2016	19	95	45 (3)	1,234
2017	24	70	22 (1)	1,672
2018	19	156	1	1,903
2019	18	47	2	2,450
2020	9	49	21 (21)	2,465
2021	12	78	6	2,835
2022	13	143	2	4,084
2023	15	55	10	3,775
2024	18	56	2	3,931
2025	16	63	3	4,539
2026	17	59	23 (21)	—

What is it indicated for?

Cordis Catheter Sheath Introducers are intended for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.

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

https://510kreport.com/device/K984500 · printed Nov 6, 2026

Cite this page

510(k) Report. “K984500: Cordis Brite Tip Catheter Sheath Introducer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984500

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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