Cleared Traditional

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

K882507 is the FDA 510(k) clearance for ACS 0.015 & 0.018 PRESSURE GUIDE WIRE W... by Advanced Cardiovascular Systems, Inc.. It is a Class 2 Cardiovascular device (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

Submission Details

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.

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 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