Cleared Traditional

K904984 - ADVANCE 418(TM)

K904984 is an FDA 510(k) clearance for ADVANCE 418(TM), manufactured by Peripheral Systems Group. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 161-day FDA review.

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

FDA 510(k) Submission Details - K904984

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.

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 K904984.
CORDIS OPTA 5
K905698 · Cordis Corp. · Jul 1991
OPTI-PLAST 5F PTA CATHETERS OVEN CURING PROCEDURE
K911639 · Vas-Cath, Inc. · Jun 1991
STEALTH CATHETER SYSTEM
K911089 · Target Therapeutics · May 1991
MEDI-TECH BALLOON DILATATION CATHETER
K910995 · Boston Scientific Corp · Apr 1991
OPTI-PLAST 5F PTA CATHETERS
K910996 · Vas-Cath, Inc. · Apr 1991
TEGWIRE (TM)
K911203 · Boston Scientific Corp · Apr 1991