510(k) · Cleared
Recalled · 2003Cordis 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 Jul 21, 1997 as substantially equivalent to K954595 (Cordis Corp., 1995) after an 81-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 21, 1997
- Review
- 81 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954595 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK954595 Cordis Brite Tip Sheath IntroducerCordis Corp. · 1995 · Recalled
- This deviceK971608 Cordis Brite Tip Catheter Sheath Introducer SystemCordis Corp. · 1997
- Descendant · cites it directly · 0 of its ownK974448 Cordis Brite Tip Catheter Sheath Introducer SystemCordis Corp. · 1998
Most influential descendants
Showing 1 of 1 · See all- K974448Cordis Brite Tip Catheter Sheath Introducer SystemCordis Corp. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954595 | Cordis Brite Tip Sheath Introducer | Cordis Corp. | 1995 | 1 |
| 0 (this device) | K971608 | Cordis Brite Tip Catheter Sheath Introducer System | Cordis Corp. | 1997 | — |
| +1 | K974448 | Cordis Brite Tip Catheter Sheath Introducer System | Cordis Corp. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 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.
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 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 |
|---|---|---|---|
| * | K954595 | Cordis Brite Tip Sheath IntroducerSummary page 1…cer or Sheath Introducer System Proprietary Name: Cordis Brite Tip® Catheter Sheath Introducer System Name of Predicate Devices Brite Tip® Catheter Sheath Introducer, K 954595, October 02, 1995 Classification Class I Performance Standards Performance standards have not been established by the FDA unde… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K974448 | Cordis Brite Tip Catheter Sheath Introducer System | 1998 | 0 |
Has anything in its family been recalled? (0 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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/K971608 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971608: 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/K971608
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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