Cleared Traditional

K901287 - INTHERM TEMPORARY OCCLUSION CATHETER (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K901287 · Interventional Therapeutics Corp. · Cardiovascular device
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Feb 1991
Decision
337d
Days
Class 2
Risk

K901287 is an FDA 510(k) clearance for the INTHERM TEMPORARY OCCLUSION CATHETER. Classified as Catheter, Flow Directed (product code DYG), Class II - Special Controls.

Submitted by Interventional Therapeutics Corp. (Mountain View, US). The FDA issued a Cleared decision on February 20, 1991 after a review of 337 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1240 - 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 K901287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1990
Decision Date February 20, 1991
Days to Decision 337 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
212d slower than avg
Panel avg: 125d · This submission: 337d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYG Catheter, Flow Directed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1240
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 - DYG Catheter, Flow Directed

All 98
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