Cleared Traditional

K161873 - Pacel Flow Directed Pacing Catheter

K161873 is the FDA 510(k) clearance for Pacel Flow Directed Pacing Catheter by St Jude Medical. It is a Class 2 Cardiovascular device (product code LDF) cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K161873 · St Jude Medical · Cardiovascular device
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Nov 2016
Decision
138d
Days
Class 2
Risk

K161873 is an FDA 510(k) clearance for the Pacel Flow Directed Pacing Catheter. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by St Jude Medical (Minnetonka, US). The FDA issued a Cleared decision on November 22, 2016 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3680 - 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 devices

Submission Details

510(k) Number K161873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2016
Decision Date November 22, 2016
Days to Decision 138 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 125d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDF Electrode, Pacemaker, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3680
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 - LDF Electrode, Pacemaker, Temporary

All 77
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K161873.
Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead
K190716 · Medtronic · Aug 2019
Temporary Cardiac Pacing Wire
K173923 · Ethicon, Inc. · Aug 2018
Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing Lead
K171253 · Medtronic · May 2017
Streamline 6495 Bipolar Temporary Myocardial Pacing Lead
K161249 · Medtronic · Aug 2016
Pacel Bipolar Pacing Catheters
K152784 · St Jude Medical · Oct 2015
Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe
K152633 · Edwards Lifesciences, LLC · Oct 2015