TORFLEX TRANSSEPTAL GUIDING SHEATH— 510(k) K013919

Name: FDA 510(k) clearance K013919
Creator: U.S. Food and Drug Administration
Published: 2002-02-22

Substantially Equivalent

Baylis Medical Co., Inc.

FDA 510(k) clearance K013919 for TORFLEX TRANSSEPTAL GUIDING SHEATH, Substantially Equivalent on 2002-02-22. Applicant: Baylis Medical Co., Inc.. Device class: 1.

Clearance details

Applicant: Baylis Medical Co., Inc.
Product code: Code DBY
Device class: Class 1
Regulation: 21 CFR 866.5520
Advisory panel: Immunology
Date received: 2001-11-27
Decision date: 2002-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, Ontario, CA

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.