PMA · Approved
ApprovedTendril DX Model 1388T & 1388K Endocardial Pacing Leads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Medical · NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
Approved on Jun 20, 1997 through premarket approval, which rests on the device’s own clinical evidence after a 406-day review. 3 later devices descend from it.
- Decided
- Jun 20, 1997
- Review
- 406 days
- Class
- Class III
- Product code
- NVN
- Recalls
- None
3 later devices descend from it, 2 citing it directly.
- This deviceP960013 Tendril DX Model 1388T & 1388K Endocardial Pacing LeadsAbbott Medical · 1997
- Descendant · cites it directly · 1 of its ownK090163 Stylet, Models 4060, 4062, 4064, 4090, 4091 and 4078St Jude Medical · 2009
- Descendant · 2 generations on · 0 of its ownK191469 Biotronik StyletsBiotronik, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK080924 Mond Rvot Stylet Models 4140, 4141, 4150, 4151St. Jude Medical, Cardiac Rhythm Management Divisi · 2008
Most influential descendants
Showing 3 of 3 · See all- K090163Stylet, Models 4060, 4062, 4064, 4090, 4091 and 4078St Jude Medical · 2009 · cites it directly1descendant
- K191469Biotronik StyletsBiotronik, Inc. · 2019 · 2 generations on0descendants
- K080924Mond Rvot Stylet Models 4140, 4141, 4150, 4151St. Jude Medical, Cardiac Rhythm Management Divisi · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P960013 | Tendril DX Model 1388T & 1388K Endocardial Pacing Leads | Abbott Medical | 1997 | — |
| +1 | K090163 | Stylet, Models 4060, 4062, 4064, 4090, 4091 and 4078 | St Jude Medical | 2009 | — |
| +2 | K191469 | Biotronik Stylets | Biotronik, Inc. | 2019 | — |
| +1 | K080924 | Mond Rvot Stylet Models 4140, 4141, 4150, 4151 | St. Jude Medical, Cardiac Rhythm Management Divisi | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2019 | 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 NVN? 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? (3)
2 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?
- Of its descendants, K090163 (St Jude Medical, 2009) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NVN devicesNVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NVN
36in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NVN
Too few NVN 510(k)s in any year since 2007 to give a median.
Recalls per year · NVN
No recall names NVN since 2007.
Adverse event reports per year · NVN
23,350in 2025
MAUDE reports naming product code NVN, 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 | 0 | — | 0 | 46 |
| 2008 | 1 | — | 0 | 64 |
| 2009 | 10 | — | 0 | 85 |
| 2010 | 10 | — | 0 | 1,853 |
| 2011 | 11 | — | 0 | 6,196 |
| 2012 | 19 | — | 0 | 5,889 |
| 2013 | 7 | — | 0 | 7,653 |
| 2014 | 5 | — | 0 | 9,886 |
| 2015 | 10 | — | 0 | 10,137 |
| 2016 | 62 | — | 0 | 9,393 |
| 2017 | 67 | — | 0 | 11,613 |
| 2018 | 86 | — | 0 | 11,519 |
| 2019 | 56 | — | 0 | 16,873 |
| 2020 | 69 | — | 0 | 16,529 |
| 2021 | 60 | — | 0 | 17,757 |
| 2022 | 43 | — | 0 | 18,200 |
| 2023 | 38 | — | 0 | 24,991 |
| 2024 | 36 | — | 0 | 22,013 |
| 2025 | 36 | — | 0 | 23,350 |
| 2026 | 35 | — | 0 | — |
https://510kreport.com/device/P960013 · printed Nov 6, 2026
Cite this page
510(k) Report. “P960013: Tendril DX Model 1388T & 1388K Endocardial Pacing Leads.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P960013
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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