Cleared Traditional

AVE ALLIANCE DILATATION CATHETER (K931384) - FDA 510(k) Clearance

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

K931384 · Applied Vascular Engineering, Inc. · Cardiovascular device
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Sep 1993
Decision
183d
Days
Class 2
Risk

K931384 is an FDA 510(k) clearance for the AVE ALLIANCE DILATATION CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Applied Vascular Engineering, Inc. (Santa Rosa, US). The FDA issued a Cleared decision on September 17, 1993 after a review of 183 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 Applied Vascular Engineering, Inc. devices

Submission Details

510(k) Number K931384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1993
Decision Date September 17, 1993
Days to Decision 183 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 125d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
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 - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 154
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K931384.
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K923611 · Boston Scientific Corp · Nov 1993
ACCEMT DG(TM) BALLOON ANGIOPLASTY CATH, MODIFIED
K924358 · Cook, Inc. · May 1993
BLUE MAX II BALLOON DDILATATION CATHETER
K921254 · Boston Scientific Corp · Dec 1992
BALLOON DILATATION CATHETER
K922610 · Boston Scientific Corp · Nov 1992