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Baylis Medical RF Septostomy Generator, Nykanen RF Septostomy Catheter, Baylis Medical Connector Cable

by Baylis Medical Co., Inc.

510(k) K990284

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK990284 Date1 Feb 2001ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DXF
Device Class
Class II
Regulation
21 CFR Part 870.5175
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The device is a catheter septostomy system that utilizes radiofrequency (RF) energy to create atrial septal defects and facilitate transseptal left heart access. It consists of the Baylis Medical RF Septostomy Generator, the Nykanen RF Septostomy Catheter, and the Baylis Medical Connector Cable.

The system is supplied as a reusable generator and connector cable with a single-use catheter. It is classified as a Class II medical device under regulation 870.5175 and received FDA 510(k) clearance (K990284) on February 1, 2001, following a traditional review process. The device is intended for cardiovascular use and is manufactured by Baylis Medical Co., Inc. in Mississauga, Ontario, Canada.

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Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Baylis Medical RF Septostomy System used for?

    The system is used to create atrial septal defects using radiofrequency energy, which facilitates transseptal left heart access during cardiovascular procedures. This allows clinicians to access the left side of the heart through the atrial septum for diagnostic or interventional purposes.

  • How is the Baylis Medical RF Septostomy System supplied and what components are reusable?

    The system is supplied as a reusable generator and connector cable paired with a single-use catheter. The generator and cable can be reprocessed and reused across multiple procedures, while the catheter is intended for one-time use only to ensure patient safety and prevent cross-contamination.

  • What regulatory pathway was used for the Baylis Medical RF Septostomy System and when was it cleared?

    The device received FDA 510(k) clearance through a traditional review process, with clearance granted on February 1, 2001, under K990284. It is classified as a Class II medical device under regulation 870.5175 for cardiovascular use.