Cleared Traditional

K013919 - TORFLEX TRANSSEPTAL GUIDING SHEATH (FDA 510(k) Clearance)

Class I Immunology device.

K013919 · Baylis Medical Co., Inc. · Immunology device
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Feb 2002
Decision
87d
Days
Class 1
Risk

K013919 is an FDA 510(k) clearance for the TORFLEX TRANSSEPTAL GUIDING SHEATH. Classified as Fab, Rhodamine, Antigen, Antiserum, Control (product code DBY), Class I - General Controls.

Submitted by Baylis Medical Co., Inc. (Mississauga, Ontario, CA). The FDA issued a Cleared decision on February 22, 2002 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5520 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Baylis Medical Co., Inc. devices

Submission Details

510(k) Number K013919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2001
Decision Date February 22, 2002
Days to Decision 87 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 104d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DBY Fab, Rhodamine, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5520
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.