Cleared Traditional

K871492 - AIS ANGIOSCOPE

K871492 is an FDA 510(k) clearance for AIS ANGIOSCOPE, manufactured by Advanced Interventional Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K871492 · Advanced Interventional Systems, Inc. · Cardiovascular device
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Sep 1987
Decision
151d
Days
Class 2
Risk

K871492 is an FDA 510(k) clearance for the AIS ANGIOSCOPE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Advanced Interventional Systems, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on September 14, 1987 after a review of 151 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 Interventional Systems, Inc. devices

FDA 510(k) Submission Details - K871492

510(k) Number K871492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1987
Decision Date September 14, 1987
Days to Decision 151 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 125d · This submission: 151d
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 713
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K871492.
STUBBIE STEERABLE GUIDEWIRE
K873543 · Target Therapeutics · Dec 1987
OLYMPUS PF-25 ULTRATHIN ANGIOSCOPE
K871517 · Olympus Corp. · Nov 1987
LAKE REGION VARIABLE STIFFNESS GUIDEWIRE (VSGW)
K871882 · Lake Region Mfg., Inc. · Sep 1987
ACS HI-TORQUE FLEX-T GUIDE WIRE (MODIFICATION)
K872220 · Advanced Cardiovascular Systems, Inc. · Aug 1987
MINISTIK MINI PUNCTURE SET CATALOG CODE #57505
K871137 · Dlp, Inc. · Jul 1987
GUIDE WIRE
K870664 · Datascope Corp. · Mar 1987