Cleared Traditional

K915723 - .10' HI-TORQUE FLOPPY, INTER. & STAND. GUIDE WIRE

K915723 is an FDA 510(k) clearance for .10' HI-TORQUE FLOPPY, 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 172-day FDA review.

K915723 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Jun 1992
Decision
172d
Days
Class 2
Risk

K915723 is an FDA 510(k) clearance for the .10' HI-TORQUE FLOPPY, INTER. & STAND. 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 June 9, 1992 after a review of 172 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 Advanced Cardiovascular Systems, Inc. devices

FDA 510(k) Submission Details - K915723

510(k) Number K915723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1991
Decision Date June 09, 1992
Days to Decision 172 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 125d · This submission: 172d
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 K915723.
JAGWIRE(TM) RECANALIZATION GUIDEWIRE
K922302 · Boston Scientific Corp · Jul 1992
SCIMED AVENUE CORONARY GUIDEWIRE INSERTION TOOL
K922410 · Scimed Life Systems, Inc. · Jul 1992
SCIMED(R) CONTROLWIRE(TM) GUIDE WIRE
K914194 · Scimed Life Systems, Inc. · Jun 1992
GUIDE WIRES, MODIFICATION
K914986 · E-Z-Em, Inc. · May 1992
STAINLESS STEEL GEN PUR INTERVENTIONAL GUIDE WIRES
K914531 · Arrow Intl., Inc. · Feb 1992
DESERET GUIDEWIRE INTRODUCER
K915496 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1992