Cleared Traditional

K821190 - GUIDE WIRE

K821190 is the FDA 510(k) clearance for GUIDE WIRE by Advanced Cardiovascular Systems, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K821190 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Aug 1982
Decision
126d
Days
Class 2
Risk

K821190 is an FDA 510(k) clearance for the GUIDE WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Advanced Cardiovascular Systems, Inc. (Santa Clara, US). The FDA issued a Cleared decision on August 31, 1982 after a review of 126 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 K821190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1982
Decision Date August 31, 1982
Days to Decision 126 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
1d slower than avg
Panel avg: 125d · This submission: 126d
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 K821190.
CARDIOVASCULAR SPRING GUIDE WIRE
K834223 · Mallinckrodt Critical Care · Feb 1984
OPEN END SPRING GUIDE
K832607 · C.R. Bard, Inc. · Dec 1983
STAINLESS STEEL GUIDE WIRE
K831839 · Quinton, Inc. · Jul 1983
CATHETER GUIDE WIRE
K820699 · Quest Medical, Inc. · Apr 1982
ARROW RADIAL ARTERY CATHETERIZATION SET
K810675 · Arrow Intl., Inc. · Mar 1981
BENZALKONIUM-HEPARIN COATED GUIDEWIRES
K802473 · Medrad, Inc. · Nov 1980