Cleared Traditional

K933019 - USCI SUPER 6 6F PTCA GUIDING CATHETER

K933019 is the FDA 510(k) clearance for USCI SUPER 6 6F PTCA GUIDING CATHETER by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (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

Submission Details

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.

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 573
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K933019.
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K933033 · Arrow Intl., Inc. · Sep 1993
CORDIS 9 F GUIDING CATHETER
K925131 · Cordis Corp. · May 1993
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K926421 · Advanced Cardiovascular Systems, Inc. · Mar 1993