Cleared Traditional

CORDIS STEERABLE GUIDEWIRE (K943340) - FDA 510(k) Clearance

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

K943340 · Cordis Corp. · Cardiovascular device
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Sep 1994
Decision
66d
Days
Class 2
Risk

K943340 is an FDA 510(k) clearance for the CORDIS STEERABLE GUIDEWIRE. 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 September 16, 1994 after a review of 66 days - a notably fast clearance cycle.

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: 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 Cordis Corp. devices

Submission Details

510(k) Number K943340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1994
Decision Date September 16, 1994
Days to Decision 66 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
59d faster than avg
Panel avg: 125d · This submission: 66d
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 K943340.
SCIMED PURSUIT EXCHANGE PTCA GUIDE WIRE
K945159 · Scimed Life Systems, Inc. · Dec 1994
THE PROMPT GUIDWIRE
K943522 · Cordis Corp. · Dec 1994
GUIDE WIRE
K942453 · Boston Scientific Corp · Dec 1994
SCIMED EN TRE' III PTCA GUIDE WIRE
K942333 · Scimed Life Systems, Inc. · Aug 1994
PLATINUM PLUS GUIDEWIRE
K935997 · Boston Scientific Corp · Jun 1994
SCIMED 0.014 PTCA GUIDE WIRE WITH ICE HYDROPHILIC COATING
K941895 · Scimed Life Systems, Inc. · May 1994