Cleared Traditional

K030062 - ADMIRAL .035 DILATATION CATHETER

K030062 is an FDA 510(k) clearance for ADMIRAL .035 DILATATION CATHETER, manufactured by Avantec Vascular Corp.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K030062 · Avantec Vascular Corp. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 2003
Decision
86d
Days
Class 2
Risk

K030062 is an FDA 510(k) clearance for the ADMIRAL .035 DILATATION CATHETER, MODELS ADL0720-80,ADL0720-135,ADL0820-80, A.... Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Avantec Vascular Corp. (Sunnyvale, US). The FDA issued a Cleared decision on April 3, 2003 after a review of 86 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Avantec Vascular Corp. devices

FDA 510(k) Submission Details - K030062

510(k) Number K030062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2003
Decision Date April 03, 2003
Days to Decision 86 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
39d faster than avg
Panel avg: 125d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIT Device Classification - Class 2, Special Controls

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 262
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K030062.
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K023504 · Cook, Inc. · Nov 2002
NUMED GHOST II PTA CATHETERS
K003972 · NuMED, Inc. · Jan 2001
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K003276 · NuMED, Inc. · Dec 2000