Cleared Traditional

K882507 - ACS 0.015 & 0.018 PRESSURE GUIDE WIRE W/MICRO.

K882507 is an FDA 510(k) clearance for ACS 0.015 & 0.018 PRESSURE GUIDE WIRE W..., 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 287-day FDA review.

K882507 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Mar 1989
Decision
287d
Days
Class 2
Risk

K882507 is an FDA 510(k) clearance for the ACS 0.015 & 0.018 PRESSURE GUIDE WIRE W/MICRO.. 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 March 31, 1989 after a review of 287 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 Cardiovascular Systems, Inc. devices

FDA 510(k) Submission Details - K882507

510(k) Number K882507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1988
Decision Date March 31, 1989
Days to Decision 287 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
162d slower than avg
Panel avg: 125d · This submission: 287d
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 K882507.
GUIDE WIRE INTRODUCER
K890807 · Datascope Corp. · Jun 1989
INTERVENTIONAL PRODUCTS - GUIDE WIRES
K890207 · E-Z-Em, Inc. · May 1989
KATZEN THROMBOLYSIS GUIDEWIRE
K883880 · Medi-Tech, Inc. · Apr 1989
ACS 0.010 HI-TORQUE FLOPPY GOLD GUIDE WIRE
K884895 · Advanced Cardiovascular Systems, Inc. · Feb 1989
INTRODUCER SAFETY SYRINGE
K884490 · Arrow Intl., Inc. · Jan 1989
USCI ADJUSTABLE TIP GUIDE WIRE
K884647 · C.R. Bard, Inc. · Jan 1989