Cleared Traditional

K926421 - ACS ET HI-FLOW/ENHANCED TORQUE CORONARY...

K926421 is the FDA 510(k) clearance for ACS ET HI-FLOW/ENHANCED TORQUE CORONARY... by Advanced Cardiovascular Systems, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K926421 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Mar 1993
Decision
90d
Days
Class 2
Risk

K926421 is an FDA 510(k) clearance for the ACS ET HI-FLOW/ENHANCED TORQUE CORONARY GUID CATH. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Advanced Cardiovascular Systems, Inc. (Temecula, US). The FDA issued a Cleared decision on March 23, 1993 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 K926421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1992
Decision Date March 23, 1993
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 588
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K926421.
USCI SUPER 6 6F PTCA GUIDING CATHETER
K933019 · C.R. Bard, Inc. · Sep 1993
GUIDING CATHETER HEMOSTASIS VALVE CAP
K933033 · Arrow Intl., Inc. · Sep 1993
CORDIS 9 F GUIDING CATHETER
K925131 · Cordis Corp. · May 1993
TRIGUIDE-PLUS GUIDING CATHETER
K923245 · Scimed Life Systems, Inc. · Feb 1993
SCIMED 6 FR. TRIGUIDE - ELITE GUIDING CATHETER
K922611 · Scimed Life Systems, Inc. · Jan 1993
CORDIS SHUTTLE CATHETER W/ SIDEHOLES
K921311 · Cordis Corp. · Sep 1992