Cleared Traditional

K942066 - ACS HI-TORQUE EXTRA S'PORT GUIDE WIRE

K942066 is an FDA 510(k) clearance for ACS HI-TORQUE EXTRA S'PORT GUIDE WIRE, manufactured by Advanced Cardiovascular Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K942066 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
80d
Days
Class 2
Risk

K942066 is an FDA 510(k) clearance for the ACS HI-TORQUE EXTRA S'PORT GUIDE WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Advanced Cardiovascular Systems, Inc. (Santa Clara, US). The FDA issued a Cleared decision on July 18, 1994 after a review of 80 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 Advanced Cardiovascular Systems, Inc. devices

FDA 510(k) Submission Details - K942066

510(k) Number K942066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1994
Decision Date July 18, 1994
Days to Decision 80 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
45d faster than avg
Panel avg: 125d · This submission: 80d
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 K942066.
SCIMED EN TRE' III PTCA GUIDE WIRE
K942333 · Scimed Life Systems, Inc. · Aug 1994
MS AMPLATZ EXTRA STIFF GUIDE WIRE
K942382 · Meadox Surgimed, Inc. · Aug 1994
CARDIOMETRICS DUALFLOW SWITCH BOX
K940984 · Cardio Metrics, Inc. · Aug 1994
PLATINUM PLUS GUIDEWIRE
K935997 · Boston Scientific Corp · Jun 1994
CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRES
K941485 · Cardio Metrics, Inc. · May 1994
SCIMED 0.014 PTCA GUIDE WIRE WITH ICE HYDROPHILIC COATING
K941895 · Scimed Life Systems, Inc. · May 1994