Cleared Special

K012913 - BARD UTAVERSE SMALL VESSEL PTA BALLOON ...

K012913 is the FDA 510(k) clearance for BARD UTAVERSE SMALL VESSEL PTA BALLOON ... by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Special 510(k) pathway after a 29-day FDA review.

K012913 · C.R. Bard, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
29d
Days
Class 2
Risk

K012913 is an FDA 510(k) clearance for the BARD UTAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on September 28, 2001 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K012913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2001
Decision Date September 28, 2001
Days to Decision 29 days
Submission Type Special
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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 K012913.
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K012083 · Medtronic Vascular · Aug 2001
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