Cleared Traditional

ADVANCE 418(TM) (K904984) - FDA 510(k) Clearance

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

K904984 · Peripheral Systems Group · Cardiovascular device
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Apr 1991
Decision
161d
Days
Class 2
Risk

K904984 is an FDA 510(k) clearance for the ADVANCE 418(TM). Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Peripheral Systems Group (Mountain View, US). The FDA issued a Cleared decision on April 12, 1991 after a review of 161 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 Peripheral Systems Group devices

Submission Details

510(k) Number K904984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1990
Decision Date April 12, 1991
Days to Decision 161 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 125d · This submission: 161d
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 K904984.
SUB-4(TM), PERIPHERAL DILATATION CATHETER
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BARD PERIPHERAL BALLOON DILATATION CATHETER
K910822 · C.R. Bard, Inc. · Aug 1991
CORDIS OPTA 5
K905698 · Cordis Corp. · Jul 1991
MEDI-TECH BALLOON DILATATION CATHETER
K910995 · Boston Scientific Corp · Apr 1991
TEGWIRE (TM)
K911203 · Boston Scientific Corp · Apr 1991
OWENS CATHETER
K896520 · Boston Scientific Corp · Mar 1991