510(k) Report

510(k) · Cleared

Cleared

ST. Jude Medical, CPS Duo Left Heart Lead Delivery System

K072864510(k) TraditionalCleared Mar 13, 2008160-day reviewClass II21 CFR 870.1380

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

St. Jude Medical, Cardiac Rhythm Management Divisi · DRB Stylet, Catheter

Cleared on Mar 13, 2008 as substantially equivalent to P030054 (Abbott Medical, 2004) and 1 other predicate after a 160-day review. Its family tree reaches back 1 generation to 2001.

Decided
Mar 13, 2008
Review
160 days
Class
Class II
Product code
DRB
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K011084 (2001). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2004: 1 other ancestorK011084 · Mandrel Guidewire Assembly · Lake Region Mfg., Inc. · 2001200020022004200620082010
Other ancestors, by generation 1 generation back: 1 other ancestor K011084 · Mandrel Guidewire Assembly · Lake Region Mfg., Inc. · 20010
  1. Root · 1 generation backK011084 Mandrel Guidewire AssemblyLake Region Mfg., Inc. · 2001
  2. This deviceK072864 ST. Jude Medical, CPS Duo Left Heart Lead Delivery SystemSt. Jude Medical, Cardiac Rhythm Management Divisi · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K011084Mandrel Guidewire AssemblyLake Region Mfg., Inc.2001—
0 (this device)K072864ST. Jude Medical, CPS Duo Left Heart Lead Delivery SystemSt. Jude Medical, Cardiac Rhythm Management Divisi2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200410
FIG. 1 — Lineage of K072864, 2001–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 DRB? 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 DRB device

  1. #1 K220280 Arrow Stiffening Styletscore 5.1 · 5 generations · no Class I recall
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
*P030054ST Jude Medical Epic HF System
Summary page 1
…Class 11, 21 CFR 870.1330 Legally marketed device to which your firm is claiming equivalence: St. Jude Medical Model 4078S approved under (P030054) and Model 4078G approved under (KOI 1084). Device Description: CPS DuoTM Left Heart Lead Deliver…
Abbott Medical200435
*K011084Mandrel Guidewire AssemblyLake Region Mfg., Inc.2001—

Also cleared against P030054: 3 other devices →

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?

  • 1 of the 2 ancestors has a recall of any class.
  • 3 other devices also cite its predicate P030054.

How does its category compare?

All DRB devices

DRB Stylet, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · DRB

1in 2022

2008: 22009: 12014: 12017: 12019: 22022: 1
2007high 2 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRB

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

Recalls per year · DRB

No recall names DRB since 2007.

Adverse event reports per year · DRB

152in 2025

2008: 52009: 42010: 542011: 282012: 402013: 532014: 672015: 662016: 562017: 632018: 402019: 822020: 922021: 972022: 942023: 822024: 1162025: 152
2007high 152 (2025) · low 0 (2007)2025

MAUDE reports naming product code DRB, 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—00
20082—05
20091—04
20100—054
20110—028
20120—040
20130—053
20141—067
20150—066
20160—056
20171—063
20180—040
20192—082
20200—092
20210—097
20221—094
20230—082
20240—0116
20250—0152
20260—0—

What is it indicated for?

The CPS DuoTM guidewire and stylet are indicated for:

Facilitation of placement of St. Jude Medical left heart leads to target vessel/site.

Indications for use as stated in the FDA summary.

Also cleared against P030054

3 other devices cite the same predicate.

  • K113773ST Jude Medical, IS4 Flushing/Funneling ToolSt Jude Medical · 2012
  • K093858Psa Cable, Models 4160 and 4161 and Psa Cable Adapter, Model 4053ASt. Jude Medical, Cardiac Rhythm Management Divisi · 2010
  • K090163Stylet, Models 4060, 4062, 4064, 4090, 4091 and 4078St Jude Medical · 2009

More from St. Jude Medical, Cardiac Rhythm…

42 FDA decisions under this applicant name. See the company

  • K122090SJM Confirm Implantable Cardiac MonitorSt. Jude Medical, Cardiac Rhythm Management Divisi · 2012
  • K120296CPS Direct Mediguide Enabled Outer CatheterSt. Jude Medical, Cardiac Rhythm Management Divisi · 2012
  • K120298CPS Excel Mediguide Enabled GuidewireSt. Jude Medical, Cardiac Rhythm Management Divisi · 2012
  • K111943Agills PF Delivery SystemSt. Jude Medical, Cardiac Rhythm Management Divisi · 2011
  • K103250CPS Direct SL II Slittable Outer CatheterSt. Jude Medical, Cardiac Rhythm Management Divisi · 2011

Recent decisions in DRB

The DRB category page

  • K220280Arrow Stiffening StyletArrow International, LLC (A subsidiary of Teleflex, Inc.) · 2022
  • K191469Biotronik StyletsBiotronik, Inc. · 2019
  • K182660GaltTWSGalt Medical Corp. · 2019
  • K170298Liberator Beacon Tip Locking StyletCook Incorporated · 2017
  • K142116LLD EZSpectranetics, Inc. · 2014

https://510kreport.com/device/K072864 · printed Nov 6, 2026

Cite this page

510(k) Report. “K072864: ST. Jude Medical, CPS Duo Left Heart Lead Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072864

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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