Cleared Special

K010471 - AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569

K010471 is an FDA 510(k) clearance for AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, manufactured by Irvine Biomedical, Inc.. The device is a Class 2 Cardiovascular device with product code DRF cleared through the Special 510(k) pathway after a 106-day FDA review.

K010471 · Irvine Biomedical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
106d
Days
Class 2
Risk

K010471 is an FDA 510(k) clearance for the AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569. Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by Irvine Biomedical, Inc. (Irvine, US). The FDA issued a Cleared decision on June 6, 2001 after a review of 106 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.

FDA 510(k) Submission Details - K010471

510(k) Number K010471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2001
Decision Date June 06, 2001
Days to Decision 106 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
19d faster than avg
Panel avg: 125d · This submission: 106d
Pathway characteristics
Modification to existing cleared device.

DRF Device Classification - Class 2, Special Controls

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 180
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K010471.
ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE
K011847 · Zynergy Cardio Vasular (Zcv), Inc. · Jul 2001
6-FRENCH, 20-ELECTRODE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER, MODELS 6U20XXX, 6B20XXX, AND 6F20XXX
K011734 · Mogul Enterprises · Jul 2001
6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722
K011766 · St Jude Medical · Jul 2001
RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER, MODEL 401XXX AND 401XXX
K002976 · St Jude Medical · Dec 2000
POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D
K003452 · Ep Technologies, Inc. · Dec 2000
BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220
K002333 · Biosense Webster, Inc. · Aug 2000
K010471 · AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569
Download PDF FDA Summary Irvine Biomedical, In…