Cleared Traditional

K881787 - ACS HI-TORQUE STANDARD & INTERMEDI. GUIDE WIRE

K881787 is an FDA 510(k) clearance for ACS HI-TORQUE STANDARD & INTERMEDI. GUI..., 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 90-day FDA review.

K881787 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Jul 1988
Decision
90d
Days
Class 2
Risk

K881787 is an FDA 510(k) clearance for the ACS HI-TORQUE STANDARD & INTERMEDI. GUIDE WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Advanced Cardiovascular Systems, Inc. (Temecula, US). The FDA issued a Cleared decision on July 25, 1988 after a review of 90 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 - K881787

510(k) Number K881787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1988
Decision Date July 25, 1988
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
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 K881787.
TAPER FLEX-TIP STEERABLE GUIDEWIRE
K880762 · Target Therapeutics · Aug 1988
ACS HI-TORQUE FLOPPY/FLOPPY II/INTER./STANDARD GW
K881897 · Advanced Cardiovascular Systems, Inc. · Aug 1988
MEDRAD OPEN ENDED GUIDEWIRE
K880332 · Medrad, Inc. · Jul 1988
ACS HI-TORQUE GUIDE WIRES
K874202 · Advanced Cardiovascular Systems, Inc. · Apr 1988
GUIDE WIRE INTRODUCER
K873972 · Target Therapeutics · Apr 1988
CORDIS STEERABLE GUIDEWIRE
K873403 · Cordis Corp. · Mar 1988