Cleared Special

K113213 - LASSO 2515 NAV ECO VARIABLE CATHETER LA...

K113213 is the FDA 510(k) clearance for LASSO 2515 NAV ECO VARIABLE CATHETER LA... by Biosense Webster, Inc.. It is a Class 2 Cardiovascular device (product code DRF) cleared through the Special 510(k) pathway after a 34-day FDA review.

K113213 · Biosense Webster, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
34d
Days
Class 2
Risk

K113213 is an FDA 510(k) clearance for the LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LI.... Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by Biosense Webster, Inc. (Diamond Bar, US). The FDA issued a Cleared decision on December 5, 2011 after a review of 34 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 Biosense Webster, Inc. devices

Submission Details

510(k) Number K113213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2011
Decision Date December 05, 2011
Days to Decision 34 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
91d faster than avg
Panel avg: 125d · This submission: 34d
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 92
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K113213.
St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter
K150631 · St Jude Medical · Apr 2015
LASSO NAV DUO LOOP CATHETER
K130602 · Biosense Webster, Inc. · Aug 2013
RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN
K120544 · St Jude Medical · Mar 2012
WEBSTER DUO-DECAPOLAR CATHETER
K101991 · Biosense Webster, Inc. · May 2011
LIVEWIRE ELECTOPHYSIOLOGY CATHETER
K102721 · St Jude Medical · Oct 2010
ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL D402058
K101955 · St Jude Medical · Oct 2010