Cleared Abbreviated

K001390 - BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES

K001390 is an FDA 510(k) clearance for BIOSENSE WEBSTER PATIENT CABLE AND LEAD..., manufactured by Biosense Webster, Inc.. The device is a Class 2 Cardiovascular device with product code DSA cleared through the Abbreviated 510(k) pathway after a 80-day FDA review.

K001390 · Biosense Webster, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2000
Decision
80d
Days
Class 2
Risk

K001390 is an FDA 510(k) clearance for the BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES. Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Biosense Webster, Inc. (Diamond Bar, US). The FDA issued a Cleared decision on July 21, 2000 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2900 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Biosense Webster, Inc. devices

FDA 510(k) Submission Details - K001390

510(k) Number K001390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2000
Decision Date July 21, 2000
Days to Decision 80 days
Submission Type Abbreviated
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
45d faster than avg
Panel avg: 125d · This submission: 80d
Pathway characteristics
Standards-based clearance path.

DSA Device Classification - Class 2, Special Controls

Product Code DSA Cable, Transducer And Electrode, Patient, (including Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2900
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 - DSA Cable, Transducer And Electrode, Patient, (including Connector)

All 71
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K001390.
DISPOSABLE TEMPORARY PACING CABLE,MODELS CPW-BV-5,CPW-LG-5,CPW-SM-5,CPW-ERA300-5,CPW-QLOC-5
K022075 · Cp Medical · Sep 2002
REUSE CLAIM FOR THE BARD ELECTROPHYSIOLOGY SURELINK, TEMPLINK, AND TEMPLINK M EXTENSION CABLES
K013598 · C.R. Bard, Inc. · Jan 2002
DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260
K012392 · Pace Medical · Sep 2001
PATIENT CABLES FOR MONITORING, I.E., ECG, EKG, SPO2, AND BP INTERFACE CABLES AND LEADWIRES
K992524 · Advantage Medical Electronics, Inc. · Mar 2000
EWC: ECG II CABLE LEADWIRE SYSTEM
K984263 · Ewc · Feb 1999
EWC: ECG CABLE AND LEADWIRE SYSTEMS
K982817 · Ewc · Sep 1998