Cleared Traditional

K934009 - ACS POWERGUIDE CORONARY GUIDING CATHETER

K934009 is an FDA 510(k) clearance for ACS POWERGUIDE CORONARY GUIDING CATHETER, 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 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

FDA 510(k) Submission Details - K934009

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.

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 K934009.
GUIDING CATHETER
K930476 · Boston Scientific Corp · Feb 1994
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K932933 · Medtronics Interventional Vascular · 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
MICROSNARE
K925439 · Microvena Corp. · Sep 1993
GUIDING CATHETER HEMOSTASIS VALVE CAP
K933033 · Arrow Intl., Inc. · Sep 1993