Cleared Traditional

K983653 - RADII DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER, MODEL # 30411 B, C AND D

K983653 is an FDA 510(k) clearance for RADII DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER, manufactured by Cardiac Pathways Corp.. The device is a Class 2 Cardiovascular device with product code DRF cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K983653 · Cardiac Pathways Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
64d
Days
Class 2
Risk

K983653 is an FDA 510(k) clearance for the RADII DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER, MODEL # 30411 B, C AND D. Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by Cardiac Pathways Corp. (Sunnyvale, US). The FDA issued a Cleared decision on December 22, 1998 after a review of 64 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cardiac Pathways Corp. devices

FDA 510(k) Submission Details - K983653

510(k) Number K983653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1998
Decision Date December 22, 1998
Days to Decision 64 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 125d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 112
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