Cleared Traditional

K915723 - .10' HI-TORQUE FLOPPY

K915723 is the FDA 510(k) clearance for .10' HI-TORQUE FLOPPY by Advanced Cardiovascular Systems, Inc.. It is a Class 2 Cardiovascular device (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

Submission Details

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.

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 501
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K915723.
JAGWIRE(TM) RECANALIZATION GUIDEWIRE
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GUIDE WIRES, MODIFICATION
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K914531 · Arrow Intl., Inc. · Feb 1992
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K915496 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1992