510(k) · Cleared
ClearedModification to Cordis Brite Tip Catheter Sheath Introducer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Corp. · DYB Introducer, Catheter
Cleared on Oct 1, 1998 after a 31-day review. The FDA summary names its predicate without a number. 2 of the 8 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it.
- Decided
- Oct 1, 1998
- Review
- 31 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly. 2 of the 8 devices in this family, counting this one, have a Class I recall.
- This deviceK983023 Modification to Cordis Brite Tip Catheter Sheath Introducer SystemCordis Corp. · 1998
- Descendant · cites it directly · 6 of its ownK020316 Cordis Trapease Permanent Vena Cava Filter with the Visease…Cordis Corp. · 2002
- 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)
- Descendant · 3 generations on · 2 of its ownK162875 Sentry IVC filterNovate Medical, Ltd. · 2017
- Descendant · 4 generations on · 1 of its ownK173236 Sentry IVC FilterNovate Medical, Ltd. · 2018
- Descendant · 3 generations on · 1 of its ownK091077 Optease Vena Cava Filter and Retrieval CatheterCordis Corp., A Johnson & Johnson Co. · 2010 · Recalled (Class I)
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 7 · See all- K020316Cordis Trapease Permanent Vena Cava Filter with the Visease Angiographic Vessel Dilator…Cordis Corp. · 2002 · cites it directly6descendants
- K034050Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable Catheter…Cordis Corporation · 2004 · 2 generations on5descendants
- K162875Sentry IVC filterNovate Medical, Ltd. · 2017 · 3 generations on2descendants
- K173236Sentry IVC FilterNovate Medical, Ltd. · 2018 · 4 generations on1descendant
- K091077Optease Vena Cava Filter and Retrieval CatheterCordis Corp., A Johnson & Johnson Co. · 2010 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983023 | Modification to Cordis Brite Tip Catheter Sheath Introducer System | Cordis Corp. | 1998 | — |
| +1 | K020316 | Cordis Trapease Permanent Vena Cava Filter with the Visease Angiographic… | Cordis Corp. | 2002 | — |
| +2 | K034050 | Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable… | Cordis Corporation | 2004 | Class I |
| +3 | K162875 | Sentry IVC filter | Novate Medical, Ltd. | 2017 | — |
| +4 | K173236 | Sentry IVC Filter | Novate Medical, Ltd. | 2018 | — |
| +3 | K091077 | Optease Vena Cava Filter and Retrieval Catheter | Cordis Corp., A Johnson & Johnson Co. | 2010 | 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 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
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.
2 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
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 | Decided |
|---|---|---|---|
| * | — | Brite Tip CSI’s Named without a submission number |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020316 | Cordis Trapease Permanent Vena Cava Filter with the Visease Angiographic Vessel Dilator… | 2002 | 6 |
Has anything in its family been recalled? (2 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.
- 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, K020316 (Cordis Corp., 2002) has gone furthest, with 6 descendants of its own.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DYB
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYB
63in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYB
3in 2025
Class I (48 since 2007) Class II/III not classified
Adverse event reports per year · DYB
4,539in 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/K983023 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983023: Modification to 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/K983023
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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