Cleared Traditional

K934602 - ACS.018 HI-TORQUE FLOPPY GUIDE WIRE - A...

K934602 is the FDA 510(k) clearance for ACS.018 HI-TORQUE FLOPPY GUIDE WIRE - A... by Advanced Cardiovascular Systems, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K934602 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Dec 1993
Decision
83d
Days
Class 2
Risk

K934602 is an FDA 510(k) clearance for the ACS.018 HI-TORQUE FLOPPY GUIDE WIRE - ACS HI-TORQUE FLOPPY EXTRA SUPPORT GUID.... 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 December 16, 1993 after a review of 83 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

Submission Details

510(k) Number K934602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1993
Decision Date December 16, 1993
Days to Decision 83 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
42d faster than avg
Panel avg: 125d · This submission: 83d
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 K934602.
SCIMED ENTRE II PTCA GUIDE WIRE
K935577 · Scimed Life Systems, Inc. · Feb 1994
MAGIC TORQUE GUIDEWIRE
K933334 · Boston Scientific Corp · Jan 1994
SCIMED ENTRE II PTCA GUIDE WIRE MODIFICATION
K935022 · Scimed Life Systems, Inc. · Jan 1994
LOC GUIDE WIRE EXTENSION
K934339 · Advanced Cardiovascular Systems, Inc. · Dec 1993
USCI MACH 10 GUIDE WIRE WITH PRO/PEL COATING
K933466 · C.R. Bard, Inc. · Oct 1993
B-D ARTERIAL BLOOD CONTAINMENT DEVICE
K925947 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1993