510(k) · Cleared
Recalled · 2009Model 6495 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 Jul 22, 1997 as substantially equivalent to K944957 (Medtronic Blood Systems, Inc., 1995) and 1 other predicate after a 298-day review. Its family tree reaches back 1 generation to 1985. It has been recalled once.
- Decided
- Jul 22, 1997
- Review
- 298 days
- Class
- Class II
- Product code
- LDF
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K850622 (1985). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK850622 Oscor Medical Model Tme 64S Bipolar Temp/Heart WirOscor Medical Corp. · 1985
- This deviceK963898 Model 6495 Bipolar Temporary Pacing LeadMedtronic Vascular · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K850622 | Oscor Medical Model Tme 64S Bipolar Temp/Heart Wir | Oscor Medical Corp. | 1985 | — |
| 0 (this device) | K963898 | Model 6495 Bipolar Temporary Pacing Lead | Medtronic Vascular | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K944957 | Temporary Myocardial Pacing Lead, Model 6500Summary page 1…tory Systems Device Panel into Class II, (21 CFR 870.3680(a)). 3. SUBSTANTIALLY Temporary Myocardial Pacing Wire, Medtronic Model EQUIVALENT DEVICE(S) 6500, marketed via K944957 Bipolar temporary Myocardial Heart Wire, Oscor Model TME 65 C, marketed via K850622 4. DEVICE DESCRIPTION The bipolar temporary… | 1995 |
| * | K850622 | Oscor Medical Model Tme 64S Bipolar Temp/Heart WirSummary page 1…orary Myocardial Pacing Wire, Medtronic Model EQUIVALENT DEVICE(S) 6500, marketed via K944957 Bipolar temporary Myocardial Heart Wire, Oscor Model TME 65 C, marketed via K850622 4. DEVICE DESCRIPTION The bipolar temporary myocardial pacing wire, Model 6495 consists of a distal electrode, proximal electro… | 1985 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 6, 2009 | Not classified | Z-1173-2009 | Process control | Medtronic is recalling one lot of STREAMLINE Bipolar Myocardial Temporary Pacing Leads, Model 6495, Lot JGD880205F. This lot of product contains incorrect inner pouch labeling, instead of 6495 it is labeled 6500. The outer carton, shelf… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K944957.
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 Model 6495 bipolar temporary myocardial pacing lead is designed for temporary atrial and ventricular pacing and sensing, for a maximum of 7 days, during and after cardiac surgery. The Model 6495 bipolar temporary myocardial pacing lead is intended for SNGLE USE ONLY.
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/K963898 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963898: Model 6495 Bipolar Temporary Pacing Lead.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963898
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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