Cleared Traditional

K101784 - MOBICATH BI-DIRECTIONAL GUIDING SHEATH ...

K101784 is an FDA 510(k) clearance for MOBICATH BI-DIRECTIONAL GUIDING SHEATH ..., manufactured by Great Batch Medical. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K101784 · Great Batch Medical · Cardiovascular device
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Nov 2010
Decision
154d
Days
Class 2
Risk

K101784 is an FDA 510(k) clearance for the MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Great Batch Medical (Plymouth, US). The FDA issued a Cleared decision on November 26, 2010 after a review of 154 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.

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FDA 510(k) Submission Details - K101784

510(k) Number K101784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2010
Decision Date November 26, 2010
Days to Decision 154 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 125d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

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 462
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K101784.
AGILIS ES STEERABLE INTRODUCER
K103083 · St Jude Medical · Apr 2011
TORFLEX TRANSSEPTAL GUIDING SHEATH
K102948 · Baylis Medical Co., Inc. · Apr 2011
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
GLIDESHEATH
K102008 · Terumo Medical Corp. · Jul 2010