510(k) · Decided
DecidedCordis Palmaz Corinthian Transhepatic Biliary Stent and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Corp. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Aug 4, 1999 as substantially equivalent to K905720 (Johnson & Johnson Interventional Systems, 1991) and 5 other predicates after a 128-day review. Its family tree reaches back 2 generations to 1991. 19 later devices descend from it.
- Decided
- Aug 4, 1999
- Review
- 128 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 2 generations to K905720 (1991). 6 ancestors in all. 19 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK905720 Palmaz Biliary StentJohnson & Johnson Interventional Systems · 1991
- 1 generation backK990631 Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery…Cordis Corp. · 1999
- This deviceK991028 Cordis Palmaz Corinthian Transhepatic Biliary Stent and AccessoriesCordis Corp. · 1999
- Descendant · cites it directly · 17 of its ownK992755 Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery…Cordis, A Johnson & Johnson Co. · 1999
- Descendant · 2 generations on · 11 of its ownK994156 Modification to Cordis Palmaz Corinthian IQ Transhepatic Biliary…Cordis Corp. · 2000
- Descendant · 2 generations on · 9 of its ownK012056 Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018…Cordis Europa, N.V. · 2001
- Descendant · cites it directly · 6 of its ownK012090 Cordis Palmaz Genesis Transhepatic Biliary StentCordis, A Johnson & Johnson Co. · 2001
- Descendant · cites it directly · 5 of its ownK012590 Cordis Palmaz Genesis Transhepatic Biliary Stent on Opta Pro .035…Cordis Corp. · 2001
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K992755Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Cordis Crimping…Cordis, A Johnson & Johnson Co. · 1999 · cites it directly17descendants
- K994156Modification to Cordis Palmaz Corinthian IQ Transhepatic Biliary Stent, Models PQ294B…Cordis Corp. · 2000 · 2 generations on11descendants
- K012056Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery SystemCordis Europa, N.V. · 2001 · 2 generations on9descendants
- K012090Cordis Palmaz Genesis Transhepatic Biliary StentCordis, A Johnson & Johnson Co. · 2001 · cites it directly6descendants
- K012590Cordis Palmaz Genesis Transhepatic Biliary Stent on Opta Pro .035 Delivery SystemCordis Corp. · 2001 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K905720 | Palmaz Biliary Stent | Johnson & Johnson Interventional Systems | 1991 | — |
| −1 | K990631 | Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Model… | Cordis Corp. | 1999 | — |
| 0 (this device) | K991028 | Cordis Palmaz Corinthian Transhepatic Biliary Stent and Accessories | Cordis Corp. | 1999 | — |
| +1 | 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 | — |
| +2 | K012056 | Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery System | Cordis Europa, N.V. | 2001 | — |
| +1 | K012090 | Cordis Palmaz Genesis Transhepatic Biliary Stent | Cordis, A Johnson & Johnson Co. | 2001 | — |
| +1 | K012590 | Cordis Palmaz Genesis Transhepatic Biliary Stent on Opta Pro .035 Delivery… | Cordis Corp. | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 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 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
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K905720 | Palmaz Biliary StentSummary page 1…featured with the Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent are substantially equivalent to those featured among predecessor Cordis biliary stents (see 510(k) #K905720, #K911581, and #K964688). Page | oy 1/ - Pfi—g& 2{» Cordis Cur purativn SIO(K) #K991028 PALMAZ CORINTHIAN Trans… | 1991 |
| * | K911581 | Palmaz (TM) Balloon-Expandable Stent, ModificationSummary page 1…ith the Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent are substantially equivalent to those featured among predecessor Cordis biliary stents (see 510(k) #K905720, #K911581, and #K964688). Page | oy 1/ - Pfi—g& 2{» Cordis Cur purativn SIO(K) #K991028 PALMAZ CORINTHIAN Transhepatic Bi… | 1991 |
| * | K964688 | Long Medium Palmaz-Schatz Balloon Expandable StentSummary page 1…PALMAZ CORINTHIAN Transhepatic Biliary Stent are substantially equivalent to those featured among predecessor Cordis biliary stents (see 510(k) #K905720, #K911581, and #K964688). Page | oy 1/ - Pfi—g& 2{» Cordis Cur purativn SIO(K) #K991028 PALMAZ CORINTHIAN Transhepatic Biliary Stent an… | 1997 |
| * | K990631 | Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Model PC125BPS… Cleared while this submission was under review Summary page 2…ry Stent reprecents a line extension to other Cordis balloon catheters that were previously determined substantially equivalent for biliary stent deployment (see 510(k) #K990631). Device Description: The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent is a balloon- expandable, stainless steel stent t… | 1999 |
| * | K971448 | Cordis Opta LP Pta Balloon CatheterSummary page 2…nt of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This is the same intended use previously cleared for this balloon catheter (via 510(k) #K971448 and #K981407). Technological Characteristics: The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent incorporates the same met… | 1997 |
| * | K981407 | Opta LP Pta Balloon Catheter/Powerflex Plus Pta Balloon CatheterSummary page 2…tive lesions of native or synthetic arteriovenous dialysis fistulae. This is the same intended use previously cleared for this balloon catheter (via 510(k) #K971448 and #K981407). Technological Characteristics: The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent incorporates the same method of deploy… | 1998 |
What descends from it? (19)
See all 193 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 8 years and passes through 2 companies; a new generation was cleared every 8.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K992755 (Cordis, A Johnson & Johnson Co., 1999) has gone furthest, with 17 descendants of its own.
- 9 other devices also cite its predicate K905720.
How does its category compare?
All FGE devicesFGE 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
2026 to Oct 25, outlined.
Median 510(k) review, days · FGE
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FGE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FGE
1,923in 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 PALMAZ CORINTHIAN Transhepatic Biliary Stent is indicated for the palliation of malignant neoplasms in the biliary tree.
Certain sizes of the OPTA LP catheters are indicated for deployment of 6-10 mm diameter X 4-10 cm length PALMAZ CORINTHIAN Transhepatic Riliary Stents. The clinical indications for these stents are described in their Instructions for Use.
Additionally, the OPTA LP catheter is intended to dilatc stenoses i iliae, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
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/K991028 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991028: Cordis Palmaz Corinthian Transhepatic Biliary Stent and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991028
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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