Cleared Traditional

K912532 - ITC HIESHIMA TAPER SELECT(TM) PERCUTANE...

K912532 is the FDA 510(k) clearance for ITC HIESHIMA TAPER SELECT(TM) PERCUTANE... by Interventional Therapeutics Corp.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K912532 · Interventional Therapeutics Corp. · Cardiovascular device
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Dec 1991
Decision
187d
Days
Class 2
Risk

K912532 is an FDA 510(k) clearance for the ITC HIESHIMA TAPER SELECT(TM) PERCUTANEOUS CATH. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Interventional Therapeutics Corp. (South San Francisco, US). The FDA issued a Cleared decision on December 11, 1991 after a review of 187 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 K912532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1991
Decision Date December 11, 1991
Days to Decision 187 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
62d slower than avg
Panel avg: 125d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 235
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K912532.
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