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K Number
K990284
Device Name
BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE
Manufacturer
BAYLIS MEDICAL CO., INC.
Date Cleared
2001-02-01

(734 days)

Product Code
DXF
Regulation Number
870.5175
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

To create an atrial septal defect in the heart. Transseptal left heart access.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information requested regarding acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for the Baylis Medical RF Septostomy System, indicating that the device has been found substantially equivalent to a legally marketed predicate device. It specifies the indications for use but does not detail acceptance criteria, performance data, study design, or ground truth establishment.

§ 870.5175 Septostomy catheter.

(a)
Identification. A septostomy catheter is a special balloon catheter that is used to create or enlarge the atrial septal defect found in the heart of certain infants.(b)
Classification. Class II (performance standards).