Cleared Traditional

INTHERM RADIALLY EXPANDING DILATING INTRODUCER (K931489) - FDA 510(k) Clearance

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

K931489 · Innerdyne Medical, Inc. · Cardiovascular device
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Oct 1993
Decision
204d
Days
Class 2
Risk

K931489 is an FDA 510(k) clearance for the INTHERM RADIALLY EXPANDING DILATING INTRODUCER. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Innerdyne Medical, Inc. (Mountain View, US). The FDA issued a Cleared decision on October 15, 1993 after a review of 204 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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 Innerdyne Medical, Inc. devices

Submission Details

510(k) Number K931489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1993
Decision Date October 15, 1993
Days to Decision 204 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
79d slower than avg
Panel avg: 125d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 259
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K931489.
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BURRON CARDIOVASCULAR ANGESTAT(TM)
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CORDIS CATHETER SHEATH INTRODUCER
K932733 · Cordis Corp. · Aug 1993
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K930057 · B.Braun Medical, Inc. · Aug 1993
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K931102 · Cordis Corp. · May 1993