Cleared Traditional

K943522 - THE PROMPT GUIDWIRE

K943522 is an FDA 510(k) clearance for THE PROMPT GUIDWIRE, manufactured by Cordis Corp.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K943522 · Cordis Corp. · Cardiovascular device
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Dec 1994
Decision
154d
Days
Class 2
Risk

K943522 is an FDA 510(k) clearance for the THE PROMPT GUIDWIRE. 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 December 19, 1994 after a review of 154 days - an extended review 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: 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 Cordis Corp. devices

FDA 510(k) Submission Details - K943522

510(k) Number K943522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1994
Decision Date December 19, 1994
Days to Decision 154 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
29d slower than avg
Panel avg: 125d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQX Device Classification - Class 2, Special Controls

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 541
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K943522.
SCIMED CHIOCE PLUS PTCA GUIDE WIRE
K945129 · Scimed Life Systems, Inc. · Mar 1995
ACS GUIDE WIRES WITH MODIFIED PACKAGE INSERT
K946029 · Advanced Cardiovascular Systems, Inc. · Feb 1995
SCIMED PURSUIT EXCHANGE PTCA GUIDE WIRE
K945159 · Scimed Life Systems, Inc. · Dec 1994
GUIDE WIRE
K942453 · Boston Scientific Corp · Dec 1994
CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRE
K943022 · Cardio Metrics, Inc. · Sep 1994
CORDIS STEERABLE GUIDEWIRE
K943340 · Cordis Corp. · Sep 1994