Cleared Traditional

K882321 - ACS DEFLECTABLE TIP GUIDE WIRE W/MICROG...

K882321 is the FDA 510(k) clearance for ACS DEFLECTABLE TIP GUIDE WIRE W/MICROG... by Advanced Cardiovascular Systems, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K882321 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Aug 1988
Decision
85d
Days
Class 2
Risk

K882321 is an FDA 510(k) clearance for the ACS DEFLECTABLE TIP GUIDE WIRE W/MICROGLIDE(R)COAT. 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 August 30, 1988 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Advanced Cardiovascular Systems, Inc. devices

Submission Details

510(k) Number K882321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1988
Decision Date August 30, 1988
Days to Decision 85 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
40d faster than avg
Panel avg: 125d · This submission: 85d
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 K882321.
TARGET THERAPEUTICS SEEKER-16 STEERABLE GUIDEWIRE
K884198 · Target Therapeutics · Dec 1988
CORONARY GUIDE WIRE
K883579 · Datascope Corp. · Nov 1988
TAD INTERMEDIATE & TAD STANDARD GUIDE WIRE
K882928 · Advanced Cardiovascular Systems, Inc. · Sep 1988
COATING FOR WIRE GUIDE
K880722 · Cook, Inc. · Aug 1988
TAPER-22 STEERABLE GUIDEWIRE
K880761 · Target Therapeutics · Aug 1988
TAPER FLEX-TIP STEERABLE GUIDEWIRE
K880762 · Target Therapeutics · Aug 1988