Cleared Traditional

K102948 - TORFLEX TRANSSEPTAL GUIDING SHEATH

K102948 is the FDA 510(k) clearance for TORFLEX TRANSSEPTAL GUIDING SHEATH by Baylis Medical Co., Inc.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K102948 · Baylis Medical Co., Inc. · Cardiovascular device
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Apr 2011
Decision
178d
Days
Class 2
Risk

K102948 is an FDA 510(k) clearance for the TORFLEX TRANSSEPTAL GUIDING SHEATH. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Baylis Medical Co., Inc. (Mississauga, Ontario, CA). The FDA issued a Cleared decision on April 1, 2011 after a review of 178 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Baylis Medical Co., Inc. devices

Submission Details

510(k) Number K102948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2010
Decision Date April 01, 2011
Days to Decision 178 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 125d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 400
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K102948.
ENGAGE/ENGAGE TR INTRODUCERS
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AGILIS ES STEERABLE INTRODUCER
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VSI MICRO-INTRODUCER SETS (REGULAR, STIFFEN), MODELS 7197V-7209V, 7240V-7256V, 7259V, 7230V, 7231V, 7260V, 7274V
K101604 · Vascular Solutions, Inc. · Jan 2011
DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY
K101497 · Oscor, Inc. · Oct 2010
6F ENGAGE/ENGAGE TR INTRODUCER
K101883 · St Jude Medical · Sep 2010