Cleared Traditional

K903463 - IVT INTRODUCER SHEATH

K903463 is the FDA 510(k) clearance for IVT INTRODUCER SHEATH by Intensive Technology, Inc.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K903463 · Intensive Technology, Inc. · Cardiovascular device
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Jan 1991
Decision
155d
Days
Class 2
Risk

K903463 is an FDA 510(k) clearance for the IVT INTRODUCER SHEATH. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Intensive Technology, Inc. (San Diego, US). The FDA issued a Cleared decision on January 3, 1991 after a review of 155 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 Intensive Technology, Inc. devices

Submission Details

510(k) Number K903463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1990
Decision Date January 03, 1991
Days to Decision 155 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 125d · This submission: 155d
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 392
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K903463.
CORDIS PEEL-AWAY INSERTION TOOL
K910688 · Cordis Corp. · May 1991
PERCUTANEOUS INTROD W/SIDEPORT/THREE-WAY STOPCOCK
K910861 · Daig Corp. · May 1991
ENTREE SHEATH INTRODUCER SYSTEM
K904475 · Cordis Corp. · Apr 1991
PERCUTANEOUS INTRODUCERS
K903530 · Davol, Inc. · Oct 1990
DATASCOPE PERCOR PERCUTANEOUS INTRODUCER W/PEELABL
K902932 · Datascope Corp. · Oct 1990
MODELS 6207/6208/6209/6210/6211/6212/6214 (PLI'S)
K900515 · Medtronic Vascular · Aug 1990