Cleared Traditional

K911869 - IVT GUIDING CATHETER

K911869 is an FDA 510(k) clearance for IVT GUIDING CATHETER, manufactured by Intensive Technology, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K911869

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.

DQY Device Classification - Class 2, Special Controls

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 803
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K911869.
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RIGHT ATRIAL CATHETERS
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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