Cleared Special

K031161 - VARIABLE LASSO 2515 CIRCULAR MAPPING CA...

K031161 is the FDA 510(k) clearance for VARIABLE LASSO 2515 CIRCULAR MAPPING CA... by Biosense Webster, Inc.. It is a Class 2 Cardiovascular device (product code DRF) cleared through the Special 510(k) pathway after a 99-day FDA review.

K031161 · Biosense Webster, Inc. · Cardiovascular device
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Jul 2003
Decision
99d
Days
Class 2
Risk

K031161 is an FDA 510(k) clearance for the VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER. 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 July 22, 2003 after a review of 99 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 K031161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2003
Decision Date July 22, 2003
Days to Decision 99 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
26d faster than avg
Panel avg: 125d · This submission: 99d
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 96
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