PMA · Approved
ApprovedDavol Long Term Epidural Catheter, Catheter with Vitacuff Antimicrobial Cuff and Repair Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · LNY Catheter, Percutaneous, Long Term, Intraspinal
Approved on Feb 29, 1988 through premarket approval, which rests on the device’s own clinical evidence after a 444-day review.
- Decided
- Feb 29, 1988
- Review
- 444 days
- Class
- Class III
- Product code
- LNY
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P860064 has 9 supplements since 1989: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 1989 | 3 |
| 1990 | 2 |
| 1991 | 1 |
| 1997 | 1 |
| 1998 | 1 |
| 2001 | 1 |
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 LNY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All LNY devicesLNY Catheter, Percutaneous, Long Term, Intraspinal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LNY
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · LNY
Too few LNY 510(k)s in any year since 2007 to give a median.
Recalls per year · LNY
No recall names LNY since 2007.
Adverse event reports per year · LNY
1in 2025
MAUDE reports naming product code LNY, 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 | 3 | — | 0 | 5 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 10 |
| 2012 | 0 | — | 0 | 30 |
| 2013 | 1 | — | 0 | 17 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/P860064 · printed Nov 6, 2026
Cite this page
510(k) Report. “P860064: Davol Long Term Epidural Catheter, Catheter with Vitacuff Antimicrobial Cuff and Repair Kit.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P860064
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026