Cleared Traditional

K922609 - ITC CATHETERS W/ HYDROMER

K922609 is the FDA 510(k) clearance for ITC CATHETERS W/ HYDROMER by Interventional Therapeutics Corp.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 332-day FDA review.

K922609 · Interventional Therapeutics Corp. · Cardiovascular device
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Apr 1993
Decision
332d
Days
Class 2
Risk

K922609 is an FDA 510(k) clearance for the ITC CATHETERS W/ HYDROMER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Interventional Therapeutics Corp. (South San Francisco, US). The FDA issued a Cleared decision on April 30, 1993 after a review of 332 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K922609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1992
Decision Date April 30, 1993
Days to Decision 332 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
207d slower than avg
Panel avg: 125d · This submission: 332d
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 483
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