Cleared Traditional

K072864 - ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM

K072864 is an FDA 510(k) clearance for ST. JUDE MEDICAL, manufactured by St. Jude Medical, Cardiac Rhythm Management Divisi. The device is a Class 2 Cardiovascular device with product code DRB cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K072864 · St. Jude Medical, Cardiac Rhythm Management Divisi · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
160d
Days
Class 2
Risk

K072864 is an FDA 510(k) clearance for the ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM. Classified as Stylet, Catheter (product code DRB), Class II - Special Controls.

Submitted by St. Jude Medical, Cardiac Rhythm Management Divisi (Sylmar, US). The FDA issued a Cleared decision on March 13, 2008 after a review of 160 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1380 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all St. Jude Medical, Cardiac Rhythm Management Divisi devices

FDA 510(k) Submission Details - K072864

510(k) Number K072864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2007
Decision Date March 13, 2008
Days to Decision 160 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 125d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRB Device Classification - Class 2, Special Controls

Product Code DRB Stylet, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1380
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DRB Stylet, Catheter

All 17
Devices cleared under the same product code (DRB) and FDA review panel - the closest regulatory comparables to K072864.
Liberator Beacon Tip Locking Stylet
K170298 · Cook Incorporated · Oct 2017
LLD EZ
K142116 · Spectranetics, Inc. · Aug 2014
STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078
K090163 · St Jude Medical · Apr 2009
SPECTRANETICS LLD CS, MODEL 518-039
K043401 · Spectranetics Corp. · Mar 2005
MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254
K010906 · Medtronic Vascular · Apr 2001
STYLET KIT, MODELS 6254,6282,6293
K003535 · Medtronic Vascular · Feb 2001