510(k) · Decided

Decided

Cordis Palmaz Blue Transhepatic Biliary Stent on Slalom .018 Delivery System

K040413510(k) TraditionalDecided Jun 21, 2004124-day reviewClass II21 CFR 876.5010

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

Cordis Europa, N.V. · FGE Stents, Drains And Dilators For The Biliary Ducts

Cleared on Jun 21, 2004 as substantially equivalent to K021345 (Cordis Corp., 2002) and 4 other predicates after a 124-day review. Its family tree reaches back 6 generations to 1991. 2 later devices descend from it.

Decided: Jun 21, 2004
Review: 124 days
Class: Class II
Product code: FGE
Recalls: None
Predicates: 5

Its longest line of descent runs back 6 generations to K905720 (1991). 16 ancestors in all, the oldest K901406 (1990). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 6 generations backK905720 Palmaz Biliary StentJohnson & Johnson Interventional Systems · 1991
5 generations backK990631 Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery…Cordis Corp. · 1999
4 generations backK991028 Cordis Palmaz Corinthian Transhepatic Biliary Stent and AccessoriesCordis Corp. · 1999
3 generations backK992755 Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery…Cordis, A Johnson & Johnson Co. · 1999
2 generations backK994156 Modification to Cordis Palmaz Corinthian IQ Transhepatic Biliary…Cordis Corp. · 2000
1 generation backK012056 Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018…Cordis Europa, N.V. · 2001
This deviceK040413 Cordis Palmaz Blue Transhepatic Biliary Stent on Slalom .018…Cordis Europa, N.V. · 2004
Descendant · cites it directly · 1 of its ownK053454 RX Herculink Elite Biliary Stent SystemGuidant Corporation · 2006
Descendant · 2 generations on · 0 of its ownK063481 Modification to RX Herculink Elite Biliary Stent SystemAbbott Vascular, Inc. · 2007

Most influential descendants

Showing 2 of 2 · See all

K053454RX Herculink Elite Biliary Stent SystemGuidant Corporation · 2006 · cites it directly1descendant
K063481Modification to RX Herculink Elite Biliary Stent SystemAbbott Vascular, Inc. · 2007 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K905720	Palmaz Biliary Stent	Johnson & Johnson Interventional Systems	1991	—
−5	K990631	Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Model…	Cordis Corp.	1999	—
−4	K991028	Cordis Palmaz Corinthian Transhepatic Biliary Stent and Accessories	Cordis Corp.	1999	—
−3	K992755	Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery System…	Cordis, A Johnson & Johnson Co.	1999	—
−2	K994156	Modification to Cordis Palmaz Corinthian IQ Transhepatic Biliary Stent, Models…	Cordis Corp.	2000	—
−1	K012056	Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery System	Cordis Europa, N.V.	2001	—
0 (this device)	K040413	Cordis Palmaz Blue Transhepatic Biliary Stent on Slalom .018 Delivery System	Cordis Europa, N.V.	2004	—
+1	K053454	RX Herculink Elite Biliary Stent System	Guidant Corporation	2006	—
+2	K063481	Modification to RX Herculink Elite Biliary Stent System	Abbott Vascular, Inc.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1991	1	0
1993	1	0
1994	1	0
1997	2	0
1998	1	0
2000	2	0
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	1	0

FIG. 1 — Lineage of K040413, 1991–2007Source: 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.

Planning a device in FGE? 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 FGE device

#1 K240464 WallFlex Biliary RX Stent System; Epic Biliary…score 14.5 · 13 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (5)

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
*	K021345	Modification to Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery… Summary page 3 …ic Predicate Devices The followint able rovides information on the redicate devices. G NSSCordis Europa,N.V. (part K021345 28Jun 2002Same intended use PALMAZ Transhepatic Biliary of Cordis Corporation) Same s…	Cordis Corp.	2002	—
*	K012056	Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery System Summary page 3 …ameters & lengths) Systemn Cordis Europa,N.V. (part K012056 1 Aug 2001 Same accessory PALMAZ GENESIS Transhepatic Biliary of Cordis Corporation)…	Cordis Europa, N.V.	2001	—
*	K901406	Anatomic Modular Knee (Amk) Posterior Stabilized Summary page 3 …on assurance level of 10- De Puy Inc. (a Johnson K901406 23 July 1990 Same material, i.e. (L605) Cobalt- Anatomic Modular & Johnson company)…	Depuy, Inc.	1990	—
*	K925072	Amk Landmark Revision Knee System Summary page 3 …F90) used for stabilizing post of Posterior stabilized De Puy Inc. (a Johnson K925072 21 Jan 1994 the knee system (implant) Anatomic Modular Knee (AMK) & Johnson company) Landmark Revision Kn…	Depuy, Inc.	1994	—
*	K933304	Anatomic Modular Knee (Amk) Posterior Stabilized Summary page 3 …knee system (implant) Anatomic Modular Knee (AMK) & Johnson company) Landmark Revision Knee Anatomic Modular De Puy Inc. (a Johnson K933304 30 August & Johnson company) 1993 Knee (AMK) Posterior Stabilized…	Depuy, Inc.	1993	—

Also cleared against K021345: 2 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K053454	RX Herculink Elite Biliary Stent System	Guidant Corporation	2006	1

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
None of the 16 ancestors has a recall.
Of its descendants, K053454 (Guidant Corporation, 2006) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K021345.

How does its category compare?

All FGE devices

FGE Stents, Drains And Dilators For The Biliary Ducts: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FGE

7in 2025

2007high 11 (2008) · low 1 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FGE

257in 2025

2007high 316 (2007) · low 49 (2016)2026

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

Recalls per year · FGE

1in 2024

2007high 93 (2008) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FGE

1,923in 2025

2007high 2,297 (2021) · low 1,006 (2007)2025

MAUDE reports naming product code FGE, 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	4	316	54	1,006
2008	11	214	93	1,465
2009	7	160	18	1,655
2010	9	81	32	1,434
2011	9	114	2	1,321
2012	8	96	4	1,183
2013	5	161	3	1,060
2014	8	156	0	1,270
2015	8	79	0	1,543
2016	4	49	0	1,453
2017	9	59	1	1,515
2018	7	215	43	1,681
2019	2	—	13	1,896
2020	4	121	1	2,182
2021	1	—	27	2,297
2022	6	101	21	1,749
2023	6	199	19	1,615
2024	6	188	1	1,948
2025	7	257	0	1,923
2026	8	153	11	—

What is it indicated for?

The Cordis Palmaz® BLUETM .018 Transhepatic Biliary Stent System is indicated for the palliation of malignant neoplasms in the biliary tree.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040413 · printed Nov 5, 2026

Cite this page

510(k) Report. “K040413: Cordis Palmaz Blue Transhepatic Biliary Stent on Slalom .018 Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040413

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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