Cleared Traditional

K081258 - VARIABLE LASSO NAV CATHETER

K081258 is the FDA 510(k) clearance for VARIABLE LASSO NAV CATHETER by Biosense Webster, Inc.. It is a Class 2 Cardiovascular device (product code DRF) cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K081258 · Biosense Webster, Inc. · Cardiovascular device
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Jan 2009
Decision
249d
Days
Class 2
Risk

K081258 is an FDA 510(k) clearance for the VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02. 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 January 6, 2009 after a review of 249 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1220 - 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 Biosense Webster, Inc. devices

Submission Details

510(k) Number K081258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2008
Decision Date January 06, 2009
Days to Decision 249 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
124d slower than avg
Panel avg: 125d · This submission: 249d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K081258.
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K080179 · St Jude Medical · Jan 2009
CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02
K080425 · Biosense Webster, Inc. · Apr 2008
REFLEXION SPIRAL VARIABLE RADIUS CATHETER
K072012 · St Jude Medical · Aug 2007
REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 402804
K062251 · St Jude Medical · Oct 2006