Cleared Traditional

K183632 - Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable

K183632 is an FDA 510(k) clearance for Diagnostic Fixed Electrophysiology Lume..., manufactured by Baylis Medical Company, Inc.. The device is a Class 2 Cardiovascular device with product code DRF cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K183632 · Baylis Medical Company, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2019
Decision
163d
Days
Class 2
Risk

K183632 is an FDA 510(k) clearance for the Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiol.... Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by Baylis Medical Company, Inc. (Mississauga, CA). The FDA issued a Cleared decision on June 7, 2019 after a review of 163 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 Baylis Medical Company, Inc. devices

FDA 510(k) Submission Details - K183632

510(k) Number K183632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2018
Decision Date June 07, 2019
Days to Decision 163 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
38d slower than avg
Panel avg: 125d · This submission: 163d
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 140
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