Cleared Traditional

K942382 - MS AMPLATZ EXTRA STIFF GUIDE WIRE

K942382 is an FDA 510(k) clearance for MS AMPLATZ EXTRA STIFF GUIDE WIRE, manufactured by Meadox Surgimed, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K942382 · Meadox Surgimed, Inc. · Cardiovascular device
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Aug 1994
Decision
95d
Days
Class 2
Risk

K942382 is an FDA 510(k) clearance for the MS AMPLATZ EXTRA STIFF GUIDE WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Meadox Surgimed, Inc. (Oakland, US). The FDA issued a Cleared decision on August 22, 1994 after a review of 95 days - within the typical 510(k) review window.

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 Meadox Surgimed, Inc. devices

FDA 510(k) Submission Details - K942382

510(k) Number K942382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1994
Decision Date August 22, 1994
Days to Decision 95 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
30d faster than avg
Panel avg: 125d · This submission: 95d
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 690
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K942382.
CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRE
K943022 · Cardio Metrics, Inc. · Sep 1994
CORDIS STEERABLE GUIDEWIRE
K943340 · Cordis Corp. · Sep 1994
SCIMED EN TRE' III PTCA GUIDE WIRE
K942333 · Scimed Life Systems, Inc. · Aug 1994
CARDIOMETRICS DUALFLOW SWITCH BOX
K940984 · Cardio Metrics, Inc. · Aug 1994
ACS HI-TORQUE EXTRA S'PORT GUIDE WIRE
K942066 · Advanced Cardiovascular Systems, Inc. · Jul 1994
PLATINUM PLUS GUIDEWIRE
K935997 · Boston Scientific Corp · Jun 1994