PMA · Approved
Recalled · Class II · 2011Cordis Ptca Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Corp. · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Approved on Oct 28, 1988 through premarket approval, which rests on the device’s own clinical evidence after a 269-day review. 29 later devices descend from it. It has been recalled 80 times.
- Decided
- Oct 28, 1988
- Review
- 269 days
- Class
- Class II
- Product code
- LOX
- Recalls
- 80
29 later devices descend from it, 7 citing it directly.
- This deviceP880003 Cordis Ptca Dilatation CatheterCordis Corp. · 1988
- Descendant · cites it directly · 11 of its ownK103808 Sapphire NCOrbusneich Medical, Inc. · 2011
- Descendant · cites it directly · 10 of its ownK110133 Empira RX Ptca Dilatation Catheter, Empria NC RX Ptca Dilatation…Creganna-Tactx Medical · 2011 · Recalled
- Descendant · 2 generations on · 9 of its ownK162209 Sapphire NC PlusOrbusneich Medical, Inc. · 2016
- Descendant · 2 generations on · 6 of its ownK111544 Glider Ptca Balloon CatheterTrireme Medical, Inc. · 2012
- Descendant · cites it directly · 5 of its ownK103657 SapphireOrbusneich Medical, Inc. · 2011
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
2011high 4 (2016) · low 0 (2020)2026
Most influential descendants
Showing 5 of 29 · See all- K103808Sapphire NCOrbusneich Medical, Inc. · 2011 · cites it directly11descendants
- K110133Empira RX Ptca Dilatation Catheter, Empria NC RX Ptca Dilatation CatheterCreganna-Tactx Medical · 2011 · cites it directly10descendants
- K162209Sapphire NC PlusOrbusneich Medical, Inc. · 2016 · 2 generations on9descendants
- K111544Glider Ptca Balloon CatheterTrireme Medical, Inc. · 2012 · 2 generations on6descendants
- K103657SapphireOrbusneich Medical, Inc. · 2011 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P880003 | Cordis Ptca Dilatation Catheter | Cordis Corp. | 1988 | — |
| +1 | K103808 | Sapphire NC | Orbusneich Medical, Inc. | 2011 | — |
| +1 | K110133 | Empira RX Ptca Dilatation Catheter, Empria NC RX Ptca Dilatation Catheter | Creganna-Tactx Medical | 2011 | 3 |
| +2 | K162209 | Sapphire NC Plus | Orbusneich Medical, Inc. | 2016 | — |
| +2 | K111544 | Glider Ptca Balloon Catheter | Trireme Medical, Inc. | 2012 | — |
| +1 | K103657 | Sapphire | Orbusneich Medical, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2021 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LOX? 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 LOX device
- #1 K254022 FLASH Flex™ Aorto-Ostial Angioplasty Systemscore 12.3 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (29)
See all 297 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103808 | Sapphire NC | 2011 | 11 |
| K110133 | Empira RX Ptca Dilatation Catheter, Empria NC RX Ptca Dilatation Catheter | 2011 | 10 |
| K103657 | Sapphire | 2011 | 5 |
| K133852 | Apollo Balloon Dilatation Catheter | 2014 | 2 |
| K153742 | Apollo Balloon Dilatation Catheter | 2016 | 1 |
| K141025 | Artimes Balloon Dilatation Catheter | 2014 | 1 |
| K123473 | Hoper Ptca Balloon Catheter | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 31, 2011 | Class II | Z-2441-2012 | Error in labeling | On 1/20/2011 Cordis Corporation , Miami Lakes, FL initiated a recall of their Sleek OTW PTA Dilatation Catheter Model #4261201X Lot #50027149 and Model #4261501X Lot #50026688. Product is incorrectly labeled. |
| Jan 31, 2011 | Class II | Z-2442-2012 | Error in labeling | On 1//20/2011 Cordis Corporation , Miami Lakes, FL initiated a recall of their Sleek OTW PTA Dilatation Catheter Model #4261201X Lot #50027149 and Model #4261501X Lot #50026688. Product is incorrectly labeled. |
| Jan 14, 2008 | Not classified | Z-0773-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0782-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0797-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0761-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0762-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0780-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0791-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0801-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0805-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0802-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0759-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0754-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0766-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0789-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0748-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0772-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0786-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0768-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0799-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0794-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0795-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0775-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0807-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0812-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0750-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0755-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0752-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0760-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0787-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0765-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0757-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0769-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0764-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0776-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0770-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0779-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0790-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0749-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0774-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0793-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0758-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0798-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0784-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0751-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0796-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0756-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0763-2008 | Process control | Slow Deflation or No Deflation |
| Jan 14, 2008 | Not classified | Z-0777-2008 | Process control | Slow Deflation or No Deflation |
The 5 latest of 50 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K103808 (Orbusneich Medical, Inc., 2011) has gone furthest, with 11 descendants of its own.
How does its category compare?
All LOX devicesLOX Catheters, Transluminal Coronary Angioplasty, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LOX
4in 2024
2007high 32 (2010) · low 0 (2025)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · LOX
241in 2024
2007high 241 (2024) · low 80 (2018)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LOX
4in 2019
2007high 80 (2008) · low 0 (2009)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LOX
1,890in 2025
2007high 2,753 (2017) · low 1,053 (2007)2025
MAUDE reports naming product code LOX, 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 | 19 | — | 1 | 1,053 |
| 2008 | 22 | — | 80 | 1,063 |
| 2009 | 28 | — | 0 | 1,353 |
| 2010 | 32 | — | 0 | 1,392 |
| 2011 | 9 | 103 | 0 | 2,090 |
| 2012 | 10 | 120 | 0 | 2,092 |
| 2013 | 6 | 123 | 0 | 2,436 |
| 2014 | 6 | 166 | 0 | 2,316 |
| 2015 | 4 | 119 | 0 | 2,060 |
| 2016 | 9 | 116 | 0 | 2,578 |
| 2017 | 6 | 113 | 0 | 2,753 |
| 2018 | 7 | 80 | 0 | 2,225 |
| 2019 | 1 | — | 4 | 2,102 |
| 2020 | 1 | — | 0 | 1,974 |
| 2021 | 6 | 167 | 0 | 1,738 |
| 2022 | 5 | 121 | 0 | 1,816 |
| 2023 | 4 | 138 | 0 | 1,720 |
| 2024 | 4 | 241 | 0 | 1,804 |
| 2025 | 0 | — | 0 | 1,890 |
| 2026 | 6 | 156 | 0 | — |
https://510kreport.com/device/P880003 · printed Nov 4, 2026
Cite this page
510(k) Report. “P880003: Cordis Ptca Dilatation Catheter.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/P880003
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026