Cleared Traditional

ILLUSION STEERABLE MICROGUIDEWIRE FOR NEUROVAC USE (K930982) - FDA 510(k) Clearance

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

K930982 · Cordis Corp. · Cardiovascular device
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Feb 1994
Decision
364d
Days
Class 2
Risk

K930982 is an FDA 510(k) clearance for the ILLUSION STEERABLE MICROGUIDEWIRE FOR NEUROVAC USE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Cordis Corp. (Miami Lakes, US). The FDA issued a Cleared decision on February 24, 1994 after a review of 364 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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. Elevated predicate reliance profile. 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 Cordis Corp. devices

Submission Details

510(k) Number K930982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1993
Decision Date February 24, 1994
Days to Decision 364 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
239d slower than avg
Panel avg: 125d · This submission: 364d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 287
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K930982.
SCIMED 0.014 PTCA GUIDE WIRE WITH ICE HYDROPHILIC COATING
K941895 · Scimed Life Systems, Inc. · May 1994
TORQUE DEVICE
K936032 · Merit Medical Systems, Inc. · Mar 1994
SCIMED ENTRE PTCA GUIDE WIRE WITH J-TIP
K935905 · Scimed Life Systems, Inc. · Mar 1994
SCIMED ENTRE II PTCA GUIDE WIRE
K935577 · Scimed Life Systems, Inc. · Feb 1994
MAGIC TORQUE GUIDEWIRE
K933334 · Boston Scientific Corp · Jan 1994
SCIMED ENTRE II PTCA GUIDE WIRE MODIFICATION
K935022 · Scimed Life Systems, Inc. · Jan 1994