Cleared Special

K102721 - LIVEWIRE ELECTOPHYSIOLOGY CATHETER

K102721 is the FDA 510(k) clearance for LIVEWIRE ELECTOPHYSIOLOGY CATHETER by St Jude Medical. It is a Class 2 Cardiovascular device (product code DRF) cleared through the Special 510(k) pathway after a 27-day FDA review.

K102721 · St Jude Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
27d
Days
Class 2
Risk

K102721 is an FDA 510(k) clearance for the LIVEWIRE ELECTOPHYSIOLOGY CATHETER. Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by St Jude Medical (Minnetonka, US). The FDA issued a Cleared decision on October 18, 2010 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1220 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all St Jude Medical devices

Submission Details

510(k) Number K102721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2010
Decision Date October 18, 2010
Days to Decision 27 days
Submission Type Special
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
98d faster than avg
Panel avg: 125d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1220
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 - DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

All 97
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K102721.
RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN
K120544 · St Jude Medical · Mar 2012
LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2
K113213 · Biosense Webster, Inc. · Dec 2011
WEBSTER DUO-DECAPOLAR CATHETER
K101991 · Biosense Webster, Inc. · May 2011
ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL D402058
K101955 · St Jude Medical · Oct 2010
INQUIRY AFOCUSII DIAGNOSTIC CATHETER
K101623 · St Jude Medical · Aug 2010
WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04,
K101345 · Biosense Webster, Inc. · Jun 2010