PMA · Approved
Recalled · 2007Scimed Ptca Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scimed Life Systems, Inc. · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Approved on Nov 28, 1986 through premarket approval, which rests on the device’s own clinical evidence after a 189-day review. 69 later devices descend from it. It has been recalled 5 times.
- Decided
- Nov 28, 1986
- Review
- 189 days
- Class
- Class II
- Product code
- LOX
- Recalls
- 5
69 later devices descend from it, 21 citing it directly.
- This deviceP860019 Scimed Ptca Dilatation CatheterScimed Life Systems, Inc. · 1986
- Descendant · cites it directly · 15 of its ownK113220 Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation…Boston Scientific Corporation · 2012 · Recalled
- 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 · cites it directly · 8 of its ownK121196 Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation…Boston Scientific Corp · 2012 · Recalled
Showing 5 of 69 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 69 · See all- K113220Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter (Over-the-Wire)Boston Scientific Corporation · 2012 · cites it directly15descendants
- 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
- K121196Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter (Over-the-Wire)Boston Scientific Corp · 2012 · cites it directly8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P860019 | Scimed Ptca Dilatation Catheter | Scimed Life Systems, Inc. | 1986 | — |
| +1 | K113220 | Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter… | Boston Scientific Corporation | 2012 | 1 |
| +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 | — |
| +1 | K121196 | Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter… | Boston Scientific Corp | 2012 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2012 | 7 | 0 |
| 2013 | 6 | 0 |
| 2014 | 6 | 0 |
| 2015 | 3 | 0 |
| 2016 | 11 | 0 |
| 2017 | 8 | 0 |
| 2018 | 5 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 6 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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? (69)
See all 6921 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113220 | Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter (Over-the-Wire) | 2012 | 15 |
| K103808 | Sapphire NC | 2011 | 11 |
| K110133 | Empira RX Ptca Dilatation Catheter, Empria NC RX Ptca Dilatation Catheter | 2011 | 10 |
| K121196 | Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter (Over-the-Wire) | 2012 | 8 |
| K121667 | NC Quantum Apex Ptca Dilatation Catheter (Monorail) | 2012 | 8 |
| K111544 | Glider Ptca Balloon Catheter | 2012 | 6 |
| K112735 | Tamarin Blue Ptca RX Dilatation Catheter | 2012 | 5 |
| K103657 | Sapphire | 2011 | 5 |
| K130714 | Progigy Support Catheter | 2013 | 4 |
| K121681 | Glider Ptca Balloon Catheter | 2012 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 1, 2007 | Not classified | Z-2165-2008 | Nonconforming Material/Component | The units within this lot may not meet thickness specifications surrounding the wire exit port wall, which may result in an air embolization if the Port Septum Wall burts. |
| Nov 1, 2005 | Not classified | Z-2166-2008 | Packaging process control | Two lots may not be correctly labeled. Specifically , a 2.5 mm x 12 mm unit was incorrectly labeled as a 3.5 x 20 mm unit on the box and tyvek label. |
| Aug 20, 2003 | Not classified | Z-0030-04 | Other | Some of the recalled catheters have a component that has levels of pyrogens above specification. |
| Aug 20, 2003 | Not classified | Z-0031-04 | Other | Some of the recalled catheters have a component that has levels of pyrogens above specification. |
| Aug 20, 2003 | Not classified | Z-0032-04 | Other | Some of the recalled catheters have a component that has levels of pyrogens above specification. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K113220 (Boston Scientific Corporation, 2012) has gone furthest, with 15 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
2026 to Oct 25, outlined.
Median 510(k) review, days · LOX
241in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LOX
4in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LOX
1,890in 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/P860019 · printed Nov 6, 2026
Cite this page
510(k) Report. “P860019: Scimed Ptca Dilatation Catheter.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P860019
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026