Cleared Traditional

K933019 - USCI SUPER 6 6F PTCA GUIDING CATHETER

K933019 is an FDA 510(k) clearance for USCI SUPER 6 6F PTCA GUIDING CATHETER, manufactured by C.R. Bard, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K933019 · C.R. Bard, Inc. · Cardiovascular device
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Sep 1993
Decision
98d
Days
Class 2
Risk

K933019 is an FDA 510(k) clearance for the USCI SUPER 6 6F PTCA GUIDING CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on September 28, 1993 after a review of 98 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 C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K933019

510(k) Number K933019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1993
Decision Date September 28, 1993
Days to Decision 98 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
27d faster than avg
Panel avg: 125d · This submission: 98d
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 780
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K933019.
GC IV CORONARY GUIDING CATHETER
K932933 · Medtronics Interventional Vascular · Feb 1994
9 FRENCH LARGE LUMEN TRIGUIDE PLUS GUIDING CATHETER
K934988 · Scimed Life Systems, Inc. · Jan 1994
ACS POWERGUIDE CORONARY GUIDING CATHETER
K934009 · Advanced Cardiovascular Systems, Inc. · Jan 1994
MICROSNARE
K925439 · Microvena Corp. · Sep 1993
GUIDING CATHETER HEMOSTASIS VALVE CAP
K933033 · Arrow Intl., Inc. · Sep 1993
TRANSSEPTAL INTRODUCER SET
K932619 · Thomas Medical Products, Inc. · Aug 1993