Cleared Traditional

K031949 - TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75

K031949 is an FDA 510(k) clearance for TORONTO RF SEPTOSTOMY CATHETER, manufactured by Baylis Medical Co., Inc.. The device is a Class 2 Cardiovascular device with product code DXF cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K031949 · Baylis Medical Co., Inc. · Cardiovascular device
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Dec 2003
Decision
169d
Days
Class 2
Risk

K031949 is an FDA 510(k) clearance for the TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75. Classified as Catheter, Septostomy (product code DXF), Class II - Special Controls.

Submitted by Baylis Medical Co., Inc. (Mississauga, Ontario, CA). The FDA issued a Cleared decision on December 10, 2003 after a review of 169 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5175 - 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 Co., Inc. devices

FDA 510(k) Submission Details - K031949

510(k) Number K031949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2003
Decision Date December 10, 2003
Days to Decision 169 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 125d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXF Device Classification - Class 2, Special Controls

Product Code DXF Catheter, Septostomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5175
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 - DXF Catheter, Septostomy

All 20
Devices cleared under the same product code (DXF) and FDA review panel - the closest regulatory comparables to K031949.
Park Blade Septostomy Catheter
K182399 · Cook Incorporated · Apr 2019
ProTrack RF Anchor Wire
K150709 · Baylis Medical Company, Inc. · Jun 2015
NRG TRANSSEPTAL NEEDLE
K073326 · Baylis Medical Co., Inc. · May 2008
PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS
K011557 · NuMED, Inc. · Jul 2001
BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE
K990284 · Baylis Medical Co., Inc. · Feb 2001
NUMED Z-5 ATRIOSEPTOSTOMY CATHETER
K001804 · NuMED, Inc. · Jul 2000