510(k) · Cleared
ClearedMedtronic Model 6416 Transvenous Bipolar Temporary Pacing Lead
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · LDF Electrode, Pacemaker, Temporary
Cleared on May 26, 1998 as substantially equivalent to K772103 (Medtronic Vascular, 1977) and 2 other predicates after a 260-day review. Its family tree reaches back 1 generation to 1977.
- Decided
- May 26, 1998
- Review
- 260 days
- Class
- Class II
- Product code
- LDF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K772103 (1977). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK772103 Bipolar Leads, Disp.Medtronic Vascular · 1977
- This deviceK973360 Medtronic Model 6416 Transvenous Bipolar Temporary Pacing LeadMedtronic Vascular · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K772103 | Bipolar Leads, Disp. | Medtronic Vascular | 1977 | — |
| 0 (this device) | K973360 | Medtronic Model 6416 Transvenous Bipolar Temporary Pacing Lead | Medtronic Vascular | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1995 | 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 LDF? 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 LDF device
- #1 K241334 Semi-Floating Temporary Pacing Electrode…score 12.1 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K772103 | Bipolar Leads, Disp.Summary page 1…ry Systems Device Panel into Class I, (21 CFR 870.3680(a)). 3. SUBSTANTIALLY EQUIVALENT DEVICE(S) Temporary Transvenous Pacing Lead, Medtronic Model 6704, marketed via K772103, K790261 Medtronic Vector X Guiding Catheter, marketed via K950179 4. DEVICE DESCRIPTION The Model 6416 lead consists of a sma… | 1977 |
| * | K790261 | Medtronic TemptronSummary page 1…s Device Panel into Class I, (21 CFR 870.3680(a)). 3. SUBSTANTIALLY EQUIVALENT DEVICE(S) Temporary Transvenous Pacing Lead, Medtronic Model 6704, marketed via K772103, K790261 Medtronic Vector X Guiding Catheter, marketed via K950179 4. DEVICE DESCRIPTION The Model 6416 lead consists of a small distal… | 1979 |
| * | K950179 | Medtronic (R) GC Iii Coronary Guiding CatheterSummary page 1…TANTIALLY EQUIVALENT DEVICE(S) Temporary Transvenous Pacing Lead, Medtronic Model 6704, marketed via K772103, K790261 Medtronic Vector X Guiding Catheter, marketed via K950179 4. DEVICE DESCRIPTION The Model 6416 lead consists of a small distal active fixation helix, tip and ring electrodes, an insulat… | 1995 |
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.
What does this lineage say?
- None of the 3 ancestors has a recall.
How does its category compare?
All LDF devicesLDF Electrode, Pacemaker, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LDF
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LDF
266in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LDF
1in 2018
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LDF
139in 2025
MAUDE reports naming product code LDF, 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 | 25 |
| 2008 | 1 | — | 2 | 18 |
| 2009 | 0 | — | 2 | 44 |
| 2010 | 0 | — | 0 | 48 |
| 2011 | 0 | — | 1 | 35 |
| 2012 | 0 | — | 1 | 68 |
| 2013 | 0 | — | 0 | 74 |
| 2014 | 1 | — | 0 | 68 |
| 2015 | 2 | — | 0 | 81 |
| 2016 | 3 | 138 | 0 | 90 |
| 2017 | 1 | — | 0 | 79 |
| 2018 | 1 | — | 1 (1) | 91 |
| 2019 | 1 | — | 0 | 130 |
| 2020 | 0 | — | 0 | 83 |
| 2021 | 0 | — | 0 | 125 |
| 2022 | 0 | — | 0 | 117 |
| 2023 | 0 | — | 0 | 212 |
| 2024 | 1 | — | 0 | 190 |
| 2025 | 5 | 266 | 0 | 139 |
| 2026 | 1 | — | 1 (1) | — |
What is it indicated for?
The Medtronic Model 6416 Temporary, Transvenous Pacing Lead System features an active fixation, bipolar lead and a soft-tipped lubricated guide catheter. The system is designed for temporary intracardiac pacing and/or EGM recording.
The system is disposable, for temporary single patient use with a contemplated implant duration of 7 days or less. The lead and accessories are supplied sterile.
The lead is introduced transvenously using the guide catheter. Once within the appropriate chamber, the helical tip electrode of the lead is actively fixed into the endocardium. After lead placement, the guide catheter is removed by sliding it over the lead’s bifurcated connector.
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/K973360 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973360: Medtronic Model 6416 Transvenous Bipolar Temporary Pacing Lead.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973360
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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