510(k) Report

510(k) · Cleared

Cleared

Medtronic Model 5058 Bipolar, Implantable, Screw-in, Ventricular/Atrial, Transvenous Lead

K962036510(k) TraditionalCleared Aug 22, 199690-day reviewClass III21 CFR 870.3680

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtronic Vascular · DTB Permanent Pacemaker Electrode

Cleared on Aug 22, 1996 as substantially equivalent to K940703 (Medtronic Vascular, 1994) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1989.

Decided
Aug 22, 1996
Review
90 days
Class
Class III
Product code
DTB
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K883743 (1989). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1994: 1 other ancestorReference device: P850089 · Capsure SP, Capsure, Capsure 2 Leads, Excellence S, Impulse, Impluse II Excellence SS, Leads · Medtronic Cardiac Rhythm Disease Management · 1986Reference device: K882452 · Medtronic Models 4057/4557 Endocardial Pacing Lead · Medtronic Vascular · 1988Reference device: K933731 · Medtronic Model 5028 Target Tip, Bipolar, Implantable, Tined, Ventricular, Transvenous Lead · Medtronic Vascular · 1994K883743 · Medtronic Model 4058 Pacing Lead · Medtronic Vascular · 1989 · recalled1986198819901992199419961998
Other ancestors, by generation 1 generation back: 1 other ancestor K883743 · Medtronic Model 4058 Pacing Lead · Medtronic Vascular · 1989 · recalled0
  1. Root · 1 generation backK883743 Medtronic Model 4058 Pacing LeadMedtronic Vascular · 1989 · Recalled
  2. This deviceK962036 Medtronic Model 5058 Bipolar, Implantable, Screw-in…Medtronic Vascular · 1996
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K883743Medtronic Model 4058 Pacing LeadMedtronic Vascular19891
0 (this device)K962036Medtronic Model 5058 Bipolar, Implantable, Screw-in, Ventricular/Atrial…Medtronic Vascular1996—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
FIG. 1 — Lineage of K962036, 1989–1996Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 DTB? 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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K940703Medtronic Model 4558M
Summary page 1
…ous screw-in pacing lead Medtronic model 5058 Bipolar, Implantable, Screw-In, Ventricular/Atrial, Transvenous Lead Permanent Pacemaker Electrode 21 CFR, Part 870.3680 K940703 / November 1994 Medtronic model 4058M Bipolar, Implantable, Screw-In, Ventricular/Atrial, Transvenous Lead K883743 / January 19…
Medtronic Vascular19941
*K883743Medtronic Model 4058 Pacing Lead
Summary page 1
…Permanent Pacemaker Electrode 21 CFR, Part 870.3680 K940703 / November 1994 Medtronic model 4058M Bipolar, Implantable, Screw-In, Ventricular/Atrial, Transvenous Lead K883743 / January 1989 MEDTRONIC CONFIDENTIAL D.Device Description The Medtronic model 5058 transvenous screw-in pacing…
Medtronic Vascular19891
†P850089Capsure SP, Capsure, Capsure 2 Leads, Excellence S, Impulse, Impluse II Excellence SS…Medtronic Cardiac Rhythm Disease Management1986—
†K882452Medtronic Models 4057/4557 Endocardial Pacing LeadMedtronic Vascular1988—
†K933731Medtronic Model 5028 Target Tip, Bipolar, Implantable, Tined, Ventricular, Transvenous…Medtronic Vascular1994—

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?

  • 2 of the 2 ancestors have a recall of any class.

How does its category compare?

All DTB devices

DTB Permanent Pacemaker Electrode: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTB

1in 2025

2015: 32016: 82017: 52018: 62019: 72020: 62021: 32022: 42023: 72024: 32025: 12026 (partial year): 2
2007high 8 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTB

Too few DTB 510(k)s in any year since 2007 to give a median.

Recalls per year · DTB

1in 2015

2008: 12009: 22010: 22015: 1
2007high 2 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DTB

25,591in 2025

2007: 5,4012008: 6,4692009: 7,5652010: 14,2852011: 12,5552012: 12,2302013: 10,1022014: 13,3242015: 11,0712016: 11,8392017: 11,4952018: 15,2092019: 16,8122020: 17,8592021: 18,4422022: 19,4442023: 34,5422024: 25,6892025: 25,591
2007high 34,542 (2023) · low 5,401 (2007)2025

MAUDE reports naming product code DTB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—05,401
20080—16,469
20090—27,565
20100—214,285
20110—012,555
20120—012,230
20130—010,102
20140—013,324
20153—111,071
20168—011,839
20175—011,495
20186—015,209
20197—016,812
20206—017,859
20213—018,442
20224—019,444
20237—034,542
20243—025,689
20251—025,591
20262—0—

What is it indicated for?

The model 5058 screw-in lead is indicated for pacing and sensing applications in either the atrium or the ventricle. This lead has application where implantable permanent atrial or ventricular, single chamber or dual chamber pacing systems are indicated. This permanent pacemaker lead is used to provide channeled electrically conductive pathways between the pulse generator and the heart.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Medtronic Vascular

1,057 FDA decisions under this applicant name. See the company

  • P160043/S096Resolute Onyx Zotarolimus-Eluting Coronary Stent SystemsMedtronic Vascular · 2026
  • P160043/S095Resolute Onyx Zotarolimus-Eluting Coronary Stent SystemMedtronic Vascular · 2026
  • P160043/S094Resolute Onyx Zotarolimus-Eluting Coronary Stent System; Onyx Frontier Zotarolimus-Eluting Coronary Stent…Medtronic Vascular · 2026
  • P160043/S093Resolute Onyx Zotarolimus-Eluting Coronary Stent SystemMedtronic Vascular · 2026
  • P160043/S092Resolute Onyx Zotarolimus-Eluting Coronary Stent System; Onyx Frontier Zotarolimus-Eluting Coronary Stent…Medtronic Vascular · 2026

Recent decisions in DTB

The DTB category page

https://510kreport.com/device/K962036 · printed Nov 6, 2026

Cite this page

510(k) Report. “K962036: Medtronic Model 5058 Bipolar, Implantable, Screw-in, Ventricular/Atrial, Transvenous Lead.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962036

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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