Cleared Traditional

K900756 - ITC INTRODUCER CATHETER

K900756 is the FDA 510(k) clearance for ITC INTRODUCER CATHETER by Interventional Therapeutics Corp.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K900756 · Interventional Therapeutics Corp. · Cardiovascular device
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Aug 1990
Decision
173d
Days
Class 2
Risk

K900756 is an FDA 510(k) clearance for the ITC INTRODUCER CATHETER. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Interventional Therapeutics Corp. (South San Francisco, US). The FDA issued a Cleared decision on August 8, 1990 after a review of 173 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 Interventional Therapeutics Corp. devices

Submission Details

510(k) Number K900756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1990
Decision Date August 08, 1990
Days to Decision 173 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 125d · This submission: 173d
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 325
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