Cleared Traditional

K911869 - IVT GUIDING CATHETER

K911869 is the FDA 510(k) clearance for IVT GUIDING CATHETER by Intensive Technology, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K911869 · Intensive Technology, Inc. · Cardiovascular device
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Oct 1991
Decision
173d
Days
Class 2
Risk

K911869 is an FDA 510(k) clearance for the IVT GUIDING CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Intensive Technology, Inc. (San Diego, US). The FDA issued a Cleared decision on October 16, 1991 after a review of 173 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 K911869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1991
Decision Date October 16, 1991
Days to Decision 173 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
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 DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 582
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K911869.
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CORDIS PTCA GUIDING CATHETER, MODIFICATION
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RIGHT ATRIAL CATHETERS
K911333 · Akcess Medical Products, Inc. · Sep 1991
PROFUSE INFUSION SYSTEM
K912877 · Lake Region Mfg., Inc. · Sep 1991
CORDIS 7 FRENCH 0.072 I.D. PTCA GUIDING CATHETER
K912777 · Cordis Corp. · Sep 1991