Cleared Traditional

K874776 - ACS 0.025-IN HI-TORQ MODIF J/STAND TELE...

K874776 is the FDA 510(k) clearance for ACS 0.025-IN HI-TORQ MODIF J/STAND TELE... by Advanced Cardiovascular Systems, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K874776 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Feb 1988
Decision
90d
Days
Class 2
Risk

K874776 is an FDA 510(k) clearance for the ACS 0.025-IN HI-TORQ MODIF J/STAND TELESC GUIDEWIR. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Advanced Cardiovascular Systems, Inc. (Mountain View, US). The FDA issued a Cleared decision on February 17, 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

Submission Details

510(k) Number K874776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1987
Decision Date February 17, 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.

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 K874776.
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
TELEFLEX STEERABLE GUIDEWIRE
K871850 · Teleflexmedical, Inc. · Jan 1988
STUBBIE STEERABLE GUIDEWIRE
K873543 · Target Therapeutics · Dec 1987
OLYMPUS PF-25 ULTRATHIN ANGIOSCOPE
K871517 · Olympus Corp. · Nov 1987