Cleared Traditional

K934009 - ACS POWERGUIDE CORONARY GUIDING CATHETER

K934009 is the FDA 510(k) clearance for ACS POWERGUIDE CORONARY GUIDING CATHETER by Advanced Cardiovascular Systems, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K934009 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Jan 1994
Decision
146d
Days
Class 2
Risk

K934009 is an FDA 510(k) clearance for the ACS POWERGUIDE CORONARY GUIDING CATHETER. 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 January 11, 1994 after a review of 146 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 K934009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1993
Decision Date January 11, 1994
Days to Decision 146 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
21d slower than avg
Panel avg: 125d · This submission: 146d
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 K934009.
ENVOY GUIDING CATHETER
K940187 · Cordis Neurovascular, Inc. · Mar 1994
GUIDING CATHETER
K930476 · Boston Scientific Corp · Feb 1994
9 FRENCH LARGE LUMEN TRIGUIDE PLUS GUIDING CATHETER
K934988 · Scimed Life Systems, Inc. · Jan 1994
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