510(k) · Cleared

Cleared

Perflex Stainless Steel Stent and Delivery System

K980653510(k) TraditionalCleared Jun 9, 1998118-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 Corp. · FGE Stents, Drains And Dilators For The Biliary Ducts

Cleared on Jun 9, 1998 as substantially equivalent to K905720 (Johnson & Johnson Interventional Systems, 1991) and 11 other predicates after a 118-day review. Its family tree reaches back 3 generations to 1991. 7 later devices descend from it.

Decided: Jun 9, 1998
Review: 118 days
Class: Class II
Product code: FGE
Recalls: None
Predicates: 12

Its longest line of descent runs back 3 generations to K911292 (1991). 15 ancestors in all, the oldest K885180 (1989). 7 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 3 generations backK911292 Schneider Wallstent (R)Pfizer Hospital Products Group, Inc. · 1991
2 generations backK961262 Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic…Boston Scientific Scimed, Inc. · 1996
1 generation backK964119 Wallstent Transhepatic Biliary EndoprosthesisBoston Scientific Scimed, Inc. · 1997 · Recalled
This deviceK980653 Perflex Stainless Steel Stent and Delivery SystemCordis Corp. · 1998
Descendant · cites it directly · 3 of its ownK991929 IntrastentIntratherapeutics, Inc. · 1999
Descendant · cites it directly · 2 of its ownK992319 RX Megalink SDS Biliary Stent System, Otw Megalink SDS Biliary Stent…Guidant Corp. · 1999
Descendant · 2 generations on · 1 of its ownK993904 Intrastent Doublestrut LDIntratherapeutics, Inc. · 2000 · Recalled
Descendant · 2 generations on · 0 of its ownK060817 Omnilink. 018 Biliary Stent SystemGuidant Endovascular Solutions, Inc. · 2006
Descendant · 2 generations on · 0 of its ownK053459 Omnilink .035 Biliary Stent SystemGuidant Corporation · 2006

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

1999high 3 (1999) · low 0 (2001)2026

Most influential descendants

Showing 5 of 7 · See all

K991929IntrastentIntratherapeutics, Inc. · 1999 · cites it directly3descendants
K992319RX Megalink SDS Biliary Stent System, Otw Megalink SDS Biliary Stent SystemGuidant Corp. · 1999 · cites it directly2descendants
K993904Intrastent Doublestrut LDIntratherapeutics, Inc. · 2000 · 2 generations on1descendant
K060817Omnilink. 018 Biliary Stent SystemGuidant Endovascular Solutions, Inc. · 2006 · 2 generations on0descendants
K053459Omnilink .035 Biliary Stent SystemGuidant Corporation · 2006 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K911292	Schneider Wallstent (R)	Pfizer Hospital Products Group, Inc.	1991	—
−2	K961262	Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic Biliary…	Boston Scientific Scimed, Inc.	1996	—
−1	K964119	Wallstent Transhepatic Biliary Endoprosthesis	Boston Scientific Scimed, Inc.	1997	6
0 (this device)	K980653	Perflex Stainless Steel Stent and Delivery System	Cordis Corp.	1998	—
+1	K991929	Intrastent	Intratherapeutics, Inc.	1999	—
+1	K992319	RX Megalink SDS Biliary Stent System, Otw Megalink SDS Biliary Stent System	Guidant Corp.	1999	—
+2	K993904	Intrastent Doublestrut LD	Intratherapeutics, Inc.	2000	1
+2	K060817	Omnilink. 018 Biliary Stent System	Guidant Endovascular Solutions, Inc.	2006	—
+2	K053459	Omnilink .035 Biliary Stent System	Guidant Corporation	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	3	0
1990	1	0
1991	3	0
1992	1	0
1994	1	0
1996	1	0
1997	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	3	0
2000	1	0
2002	1	0
2006	2	0

FIG. 1 — Lineage of K980653, 1991–2006Source: 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? (12)

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
*	K905720	Palmaz Biliary Stent Summary page 1 …featured with the Cordis PERFLEX Stainless Steel Stent and Delivery System are substantially equivalent to those featured among predecessor Cordis devices (see 510(k) #K905720, #K911581, #K 955728, #K964688, and #K972825) and competitive medical devices, such as the Continued... Page E2…	Johnson & Johnson Interventional Systems	1991	—
*	K911581	Palmaz (TM) Balloon-Expandable Stent, Modification Summary page 1 …ith the Cordis PERFLEX Stainless Steel Stent and Delivery System are substantially equivalent to those featured among predecessor Cordis devices (see 510(k) #K905720, #K911581, #K 955728, #K964688, and #K972825) and competitive medical devices, such as the Continued... Page E2 Cordis PE…	Johnson & Johnson Interventional Systems	1991	—
*	K955728	Cordis Biliary Stent Summary page 1 …rdis PERFLEX Stainless Steel Stent and Delivery System are substantially equivalent to those featured among predecessor Cordis devices (see 510(k) #K905720, #K911581, #K 955728, #K964688, and #K972825) and competitive medical devices, such as the Continued... Page E2 Cordis PERFLEX Stainl…	Cordis Corp.	1996	—
*	K964688	Long Medium Palmaz-Schatz Balloon Expandable Stent Summary page 1 …X Stainless Steel Stent and Delivery System are substantially equivalent to those featured among predecessor Cordis devices (see 510(k) #K905720, #K911581, #K 955728, #K964688, and #K972825) and competitive medical devices, such as the Continued... Page E2 Cordis PERFLEX Stainless Steel…	Cordis Corp.	1997	—
*	K972825	OPTA5 Pta Balloon Catheter, Powerflex Pta Balloon Catheter, Ultra-Thin Diamond Balloon… Summary page 1 …eel Stent and Delivery System are substantially equivalent to those featured among predecessor Cordis devices (see 510(k) #K905720, #K911581, #K 955728, #K964688, and #K972825) and competitive medical devices, such as the Continued... Page E2 Cordis PERFLEX Stainless Steel Stent and Deli…	Cordis Corp.	1997	—
*	K885180	Expandable Biliary Stent Endoprosthesis Summary page 2 …d... Page E2 Cordis PERFLEX Stainless Steel Stent and Delivery System 510(k) Summary Schneider WallStent Biliary Transhepatic Endoprosthesis (see 510(k) #K885180, #K 896163, #K911292, #K914277, #K923993, #K961262, and #K964119). In short, the Cordis PERFLEX Stainless Steel Stent and Deliv…	Schneider Intl., Ltd.	1989	—
*	K896163	Schneider Stent Wallstent Endoscopic Biliary Endo. Summary page 2 …2 Cordis PERFLEX Stainless Steel Stent and Delivery System 510(k) Summary Schneider WallStent Biliary Transhepatic Endoprosthesis (see 510(k) #K885180, #K 896163, #K911292, #K914277, #K923993, #K961262, and #K964119). In short, the Cordis PERFLEX Stainless Steel Stent and Delivery System r…	Schneider Stent	1989	—
*	K911292	Schneider Wallstent (R) Summary page 2 …2 === Cordis PERFLEX Stainless Steel Stent and Delivery System 510(k) Summary Schneider WallStent Biliary Transhepatic Endoprosthesis (see 510(k) #K885180, #K 896163, #K911292, #K914277, #K923993, #K961262, and #K964119). In short, the Cordis PERFLEX Stainless Steel Stent and Delivery System represents…	Pfizer Hospital Products Group, Inc.	1991	—
*	K914277	Wallstent (R) Trans Biliary Endo W/Unistep Deliv SY Summary page 2 …dis PERFLEX Stainless Steel Stent and Delivery System 510(k) Summary Schneider WallStent Biliary Transhepatic Endoprosthesis (see 510(k) #K885180, #K 896163, #K911292, #K914277, #K923993, #K961262, and #K964119). In short, the Cordis PERFLEX Stainless Steel Stent and Delivery System represents a line ex…	Schneider U.S. Stent Div.	1991	—
*	K923993	Wallstent Biliary Endoprotheses Summary page 2 …X Stainless Steel Stent and Delivery System 510(k) Summary Schneider WallStent Biliary Transhepatic Endoprosthesis (see 510(k) #K885180, #K 896163, #K911292, #K914277, #K923993, #K961262, and #K964119). In short, the Cordis PERFLEX Stainless Steel Stent and Delivery System represents a line extension to…	Schneider U.S. Stent Div.	1994	—
*	K961262	Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic Biliary Endoprosthesis Summary page 2 …s Steel Stent and Delivery System 510(k) Summary Schneider WallStent Biliary Transhepatic Endoprosthesis (see 510(k) #K885180, #K 896163, #K911292, #K914277, #K923993, #K961262, and #K964119). In short, the Cordis PERFLEX Stainless Steel Stent and Delivery System represents a line extension to the Cordi…	Boston Scientific Scimed, Inc.	1996	—
*	K964119	Wallstent Transhepatic Biliary Endoprosthesis Summary page 2 …and Delivery System 510(k) Summary Schneider WallStent Biliary Transhepatic Endoprosthesis (see 510(k) #K885180, #K 896163, #K911292, #K914277, #K923993, #K961262, and #K964119). In short, the Cordis PERFLEX Stainless Steel Stent and Delivery System represents a line extension to the Cordis Biliary Sten…	Boston Scientific Scimed, Inc.	1997	6

Also cleared against K905720: 9 other devices →

What descends from it? (7)

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

Number	Device	Applicant	Decided	Descendants
K991929	Intrastent	Intratherapeutics, Inc.	1999	3
K992319	RX Megalink SDS Biliary Stent System, Otw Megalink SDS Biliary Stent System	Guidant Corp.	1999	2
K992816	Modification to Intrastent	Intratherapeutics, Inc.	1999	0

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 7 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
1 of the 15 ancestors has a recall of any class.
Of its descendants, K991929 (Intratherapeutics, Inc., 1999) has gone furthest, with 3 descendants of its own.
9 other devices also cite its predicate K905720.

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 PERFLEX Stainless Steel Stent and Delivery System is indicated for the palliation of malignant neoplasms in the biliary tree.

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/K980653 · printed Nov 4, 2026

Cite this page

510(k) Report. “K980653: Perflex Stainless Steel Stent and Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980653

Report an extraction error

Are you the manufacturer?

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