Cleared Traditional

K990284 - BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE

K990284 is an FDA 510(k) clearance for BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, 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 734-day FDA review.

K990284 · Baylis Medical Co., Inc. · Cardiovascular device
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Feb 2001
Decision
734d
Days
Class 2
Risk

K990284 is an FDA 510(k) clearance for the BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLI.... Classified as Catheter, Septostomy (product code DXF), Class II - Special Controls.

Submitted by Baylis Medical Co., Inc. (Mississauga, CA). The FDA issued a Cleared decision on February 1, 2001 after a review of 734 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Baylis Medical Co., Inc. devices

FDA 510(k) Submission Details - K990284

510(k) Number K990284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1999
Decision Date February 01, 2001
Days to Decision 734 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
609d slower than avg
Panel avg: 125d · This submission: 734d
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 K990284.
NRG TRANSSEPTAL NEEDLE
K073326 · Baylis Medical Co., Inc. · May 2008
TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75
K031949 · Baylis Medical Co., Inc. · Dec 2003
PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS
K011557 · NuMED, Inc. · Jul 2001
NUMED Z-5 ATRIOSEPTOSTOMY CATHETER
K001804 · NuMED, Inc. · Jul 2000
REGULATED PRESSURE INJECTOR
K860806 · Target Therapeutics · Mar 1986
BLADE SEPTOSTOMY CATHETER
K801031 · Cook, Inc. · Jul 1980