Cleared Traditional

K926421 - ACS ET HI-FLOW/ENHANCED TORQUE CORONARY GUID CATH

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

K926421 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K926421

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.

DQY Device Classification - Class 2, Special Controls

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 793
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K926421.
TRANSSEPTAL INTRODUCER SET
K932619 · Thomas Medical Products, Inc. · Aug 1993
CORDIS 9 F GUIDING CATHETER
K925131 · Cordis Corp. · May 1993
ITC CATHETERS W/ HYDROMER
K922609 · Interventional Therapeutics Corp. · Apr 1993
TRIGUIDE-PLUS GUIDING CATHETER
K923245 · Scimed Life Systems, Inc. · Feb 1993
GUIDING CATHETER
K923518 · Interventional Therapeutics Corp. · Jan 1993
SCIMED 6 FR. TRIGUIDE - ELITE GUIDING CATHETER
K922611 · Scimed Life Systems, Inc. · Jan 1993