Cleared Special

K121856 - ULTRAVERSE 014 AND 018 PTA BALLOON DILA...

K121856 is the FDA 510(k) clearance for ULTRAVERSE 014 AND 018 PTA BALLOON DILA... by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Special 510(k) pathway after a 15-day FDA review.

K121856 · C.R. Bard, Inc. · Cardiovascular device
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Jul 2012
Decision
15d
Days
Class 2
Risk

K121856 is an FDA 510(k) clearance for the ULTRAVERSE 014 AND 018 PTA BALLOON DILATATION CATHETERS LINE EXTENSION. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on July 11, 2012 after a review of 15 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 K121856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2012
Decision Date July 11, 2012
Days to Decision 15 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
110d faster than avg
Panel avg: 125d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
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 - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 215
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K121856.
PASSEO-35
K130161 · Biotronik, Inc. · Apr 2013
PACIFIC PLUS
K123358 · Medtronic Vascular · Jan 2013
ATLAS GOLD PTA DILATATION CATHETER
K122984 · C.R. Bard, Inc. · Oct 2012
AMPHIRION PLUS PTA CATHETER
K121265 · Medtronic, Inc. · May 2012
POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
K112797 · Cordis Corp. · May 2012
GLADIATOR PTA BALLOON DILATION CATHETER
K113681 · Boston Scientific · Jan 2012