Cleared Traditional

K900386 - ACS ADVANCED CONCEPT GUIDE WIRE

K900386 is an FDA 510(k) clearance for ACS ADVANCED CONCEPT 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 134-day FDA review.

K900386 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Jun 1990
Decision
134d
Days
Class 2
Risk

K900386 is an FDA 510(k) clearance for the ACS ADVANCED CONCEPT 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 12, 1990 after a review of 134 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 Advanced Cardiovascular Systems, Inc. devices

FDA 510(k) Submission Details - K900386

510(k) Number K900386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1990
Decision Date June 12, 1990
Days to Decision 134 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 125d · This submission: 134d
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 K900386.
.018 HI-TORQUE FLOPPY GUIDE WIRE W/ PRESHAPED TIP
K902755 · Advanced Cardiovascular Systems, Inc. · Sep 1990
ACS .010 HI-TORQUE INTER. AND STANDARD GUIDE WIRE
K902207 · Advanced Cardiovascular Systems, Inc. · Aug 1990
DATASCOPE SLIDEWIRE(TM)
K901347 · Datascope Corp. · Jun 1990
INSITE STEERABLE GUIDEWIRE
K901224 · Lake Region Mfg., Inc. · Jun 1990
FLEXMEDICS GUIDEWIRE .012 ONLY
K895899 · Flexmedics · May 1990
CRAGG CONVERTIBLE WIRE
K897152 · Boston Scientific Corp · Feb 1990